Ophthalmic

Ophthalmic

Ophthalmology is an area of medicine concerned with the structure, function, and diseases of the eye. The FDA regulates ophthalmological devices under CFR Title 21 Part 886, and the devices are categorized into four subparts.

Ophthalmic Diagnostic Devices

Ophthalmic Diagnostic Devices

Ocular esthesiometer.

§886.1040
Ocular esthesiometer.
Identification. An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Adaptometer (biophotometer).

§886.1050
Adaptometer (biophotometer).
Identification. An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Anomaloscope.

§886.1070
Anomaloscope.
Identification. An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Haidinger brush.

§886.1090
Haidinger brush.
Identification. A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ophthalmic camera.

§886.1120
Ophthalmic camera.
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Classification. Class II.

Ophthalmic chair.

§886.1140
Ophthalmic chair.
Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.
Classification. Class I. The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Visual acuity chart.

§886.1150
Visual acuity chart.
Identification. A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Color vision plate illuminator.

§886.1160
Color vision plate illuminator.
Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended to properly illuminate color vision testing plates. It may include a filter.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Color vision tester.

§886.1170
Color vision tester.
Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Distometer.

§886.1190
Distometer.
Identification. A distometer is a device intended to measure the distance between the cornea and a corrective lens during refraction to help measure the change of the visual image when a lens is in place.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Optokinetic drum.

§886.1200
Optokinetic drum.
Identification. An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Corneal electrode.

§886.1220
Corneal electrode.
Identification. A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).
Classification. Class II.

Euthyscope.

§886.1250
Euthyscope.
Identification. A euthyscope is a device that is a modified AC-powered or battery-powered ophthalmoscope (a perforated mirror device intended to inspect the interior of the eye) that projects a bright light encompassing an arc of about 30 degrees onto the fundus of the eye. The center of the light bundle is blocked by a black disk covering the fovea (the central depression of the macular retinae where only cones are present and blood vessels are lacking). The device is intended for use in the treatment of amblyopia (dimness of vision without apparent disease of the eye).
Classification. Class I for the battery powered device. The battery powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. Class II for the AC-powered device.

Exophthalmometer.

§886.1270
Exophthalmometer.
Identification. An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Fixation device.

§886.1290
Fixation device.
Identification. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Afterimage flasher.

§886.1300
Afterimage flasher.
Identification. An afterimage flasher is an AC-powered light that automatically switches on and off to allow performance of an afterimage test in which the patient indicates the positions of afterimages after the light is off. The device is intended to determine harmonious/anomalous retinal correspondence (the condition in which corresponding points on the retina have the same directional value).
Classification. Class II.

Fornixscope.

§886.1320
Fornixscope.
Identification. A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Amsler grid.

§886.1330
Amsler grid.
Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Haploscope.

§886.1340
Haploscope.
Identification. A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Strabismus detection device.

§886.1342
Strabismus detection device.
Identification. A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.
Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination). (2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated: (i) Verification of lowest detectable amount of deviation; and (ii) Validation of the accuracy and precision at the lowest detectable amount of deviation. (3) Software verification, validation, and hazard analysis must be performed. (4) Optical radiation safety testing must demonstrate the device is safe per the directions for use. (5) Performance testing must demonstrate the electromagnetic compatibility of the device. (6) Performance testing must demonstrate the electrical safety of the device. (7) Labeling must include the following: (i) Summaries of non-clinical and clinical performance testing; (ii) Instructions on how to correctly use and maintain the device; (iii) Instructions and explanation of all user-interface components; and (iv) Information related to electromagnetic compatibility and optical radiation classification.

Keratoscope.

§886.1350
Keratoscope.
Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.
The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files

Visual field laser instrument.

§886.1360
Visual field laser instrument.
Identification. A visual field laser instrument is an AC-powered device intended to provide visible laser radiation that produces an interference pattern on the retina to evaluate retinal function.
Classification. Class II.

Bagolini lens.

§886.1375
Bagolini lens.
Identification. A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not obscure visualization of objects. The device is placed in a trial frame and intended to determine harmonious/anomalous retinal correspondence (a condition in which corresponding points on the retina have the same directional values).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Diagnostic condensing lens.

§886.1380
Diagnostic condensing lens.
Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Polymethylmethacrylate (PMMA) diagnostic contact lens.

§886.1385
Polymethylmethacrylate (PMMA) diagnostic contact lens.
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
Classification. Class II.

Flexible diagnostic Fresnel lens.

§886.1390
Flexible diagnostic Fresnel lens.
Identification. A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the lens of the eye).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Diagnostic Hruby fundus lens.

§886.1395
Diagnostic Hruby fundus lens.
Identification. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Maddox lens.

§886.1400
Maddox lens.
Identification. A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device is intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic trial lens set.

§886.1405
Ophthalmic trial lens set.
Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ophthalmic trial lens clip.

§886.1410
Ophthalmic trial lens clip.
Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ophthalmic trial lens frame.

§886.1415
Ophthalmic trial lens frame.
Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision testing.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic lens gauge.

§886.1420
Ophthalmic lens gauge.
Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Lens measuring instrument.

§886.1425
Lens measuring instrument.
Identification. A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ophthalmic contact lens radius measuring device.

§886.1430
Ophthalmic contact lens radius measuring device.
Identification. An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Maxwell spot.

§886.1435
Maxwell spot.
Identification. A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Corneal radius measuring device.

§886.1450
Corneal radius measuring device.
Identification. A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9, only when the device does not include computer software in the unit or topographers.

Stereopsis measuring instrument.

§886.1460
Stereopsis measuring instrument.
Identification. A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Headband mirror.

§886.1500
Headband mirror.
Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Eye movement monitor.

§886.1510
Eye movement monitor.
Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
Classification. Class II.

Ophthalmoscope.

§886.1570
Ophthalmoscope.
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
Classification. Class II.

Perimeter.

§886.1605
Perimeter.
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

AC-powered photostimulator.

§886.1630
AC-powered photostimulator.
Identification. An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).
Classification. Class II.

Ophthalmic preamplifier.

§886.1640
Ophthalmic preamplifier.
Identification. An ophthalmic preamplifier is an AC-powered or battery-powered device intended to amplify electrical signals from the eye in electroretinography (recording retinal action currents from the surface of the eyeball after stimulation by light), electrooculography (testing for retinal dysfunction by comparing the standing potential in the front and the back of the eyeball), and electromyography (recording electrical currents generated in active muscle).
Classification. Class II.

Ophthalmic bar prism.

§886.1650
Ophthalmic bar prism.
Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient's eyes.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic Fresnel prism.

§886.1655
Ophthalmic Fresnel prism.
Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Gonioscopic prism.

§886.1660
Gonioscopic prism.
Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ophthalmic rotary prism.

§886.1665
Ophthalmic rotary prism.
Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic isotope uptake probe.

§886.1670
Ophthalmic isotope uptake probe.
Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure, by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye.
Classification. Class II.

Ophthalmic projector.

§886.1680
Ophthalmic projector.
Identification. An ophthalmic projector is an AC-powered device intended to project an image on a screen for vision testing.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Pupillograph.

§886.1690
Pupillograph.
Identification. A pupillograph is an AC-powered device intended to measure the pupil of the eye by reflected light and record the responses of the pupil.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Pupillometer.

§886.1700
Pupillometer.
Identification. A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.
Classification. Class I (general controls). The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Skiascopic rack.

§886.1750
Skiascopic rack.
Identification. A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended as an aid in refraction.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ophthalmic refractometer.

§886.1760
Ophthalmic refractometer.
Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Manual refractor.

§886.1770
Manual refractor.
Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Retinoscope.

§886.1780
Retinoscope.
Identification. A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays.
Classification. (1) Class II (special controls) for the AC-powered device. (2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

Nearpoint ruler.

§886.1790
Nearpoint ruler.
Identification. A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to which the visual lines are directed when convergence is at its maximum).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Schirmer strip.

§886.1800
Schirmer strip.
Identification. A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears.
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Tangent screen (campimeter).

§886.1810
Tangent screen (campimeter).
Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Simulatan (including crossed cylinder).

§886.1840
Simulatan (including crossed cylinder).
Identification. A simulatan (including crossed cylinder) is a device that is a set of pairs of cylinder lenses that provides various equal plus and minus refractive strengths. The lenses are arranged so that the user can exchange the positions of plus and minus cylinder lenses of equal strengths. The device is intended for subjective refraction (refraction in which the patient judges whether a given object is clearly in focus, as the examiner uses different lenses).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

AC-powered slitlamp biomicroscope.

§886.1850
AC-powered slitlamp biomicroscope.
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
Classification. Class II.

Ophthalmic instrument stand.

§886.1860
Ophthalmic instrument stand.
Identification. An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store ophthalmic instruments in a readily accessible position.
Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Stereoscope.

§886.1870
Stereoscope.
Identification. A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.
Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Fusion and stereoscopic target.

§886.1880
Fusion and stereoscopic target.
Identification. A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (886.1870).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Nystagmus tape.

§886.1905
Nystagmus tape.
Identification. Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Spectacle dissociation test system.

§886.1910
Spectacle dissociation test system.
Identification. A spectacle dissociation test system is an AC-powered or battery-powered device, such as a Lancaster test system, that consists of a light source and various filters, usually red or green filters, intended to subjectively measure imbalance of ocular muscles.
Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Diurnal pattern recorder system.

§886.1925
Diurnal pattern recorder system.
Identification. A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Ability of the device to detect diurnal changes. (ii) Tolerability of the system at the corneoscleral interface in the intended use population. (2) Nonclinical testing must validate measurements in an appropriate nonclinical testing model to ensure ability to detect changes in intraocular pressure. (3) Patient-contacting components must be demonstrated to be biocompatible. (4) Any component that is intended to contact the eye must be demonstrated to be sterile throughout its intended shelf life. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance testing must demonstrate the electromagnetic compatibility and electromagnetic interference of the device. (7) Performance testing must demonstrate electrical safety of the device. (8) Labeling must include the following: (i) Warning against activities and environments that may put the user at greater risk. (ii) Specific instructions for the safe use of the device, which includes: (A) Description of all device components and instructions for assembling the device; (B) Explanations of all available programs and instructions for their use; (C) Instructions and explanation of all user-interface components; (D) Instructions on all safety features of the device; and (E) Instructions for properly maintaining the device. (iii) A summary of nonclinical testing information to describe EMC safety considerations. (iv) A summary of safety information obtained from clinical testing. (v) Patient labeling to convey information regarding appropriate use of device.

Tonometer and accessories.

§886.1930
Tonometer and accessories.
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
Classification. Class II.

Tonometer sterilizer.

§886.1940
Tonometer sterilizer.
Identification. A tonometer sterilizer is an AC-powered device intended to heat sterilize a tonometer (a device used to measure intraocular pressure).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Transilluminator.

§886.1945
Transilluminator.
Identification. A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.
Classification. Class I for the battery-powered device. The battery-powered device is also exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. Class II for the AC-powered device.

Ophthalmic Prosthetic Devices

Ophthalmic Prosthetic Devices

Ophthalmic tantalum clip.

§886.3100
Ophthalmic tantalum clip.
Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Ophthalmic conformer.

§886.3130
Ophthalmic conformer.
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Artificial eye.

§886.3200
Artificial eye.
Identification. An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9, if the device is made from the same materials, has the same chemical composition, and uses the same manufacturing processes as currently legally marketed devices.

Absorbable implant (scleral buckling method).

§886.3300
Absorbable implant (scleral buckling method).
Identification. An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.
Classification. Class II.

Eye sphere implant.

§886.3320
Eye sphere implant.
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Classification. Class II.

Extraocular orbital implant.

§886.3340
Extraocular orbital implant.
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
Classification. Class II.

Keratoprosthesis.

§886.3400
Keratoprosthesis.
Identification. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
Classification. Class II. The special controls for this device are FDA's: (1) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (2) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), and (3) Guidance on 510(k) Submissions for Keratoprostheses.

Intraocular lens.

§886.3600
Intraocular lens.
Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.
Classification. Class III.

Scleral shell.

§886.3800
Scleral shell.
Identification. A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Aqueous shunt.

§886.3920
Aqueous shunt.
Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.
Classification. Class II. The special controls for this device are FDA's: (1) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (2) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), and (3) Aqueous Shunts510(k) Submissions.

Ophthalmic Surgical Devices

Ophthalmic Surgical Devices

Powered corneal burr.

§886.4070
Powered corneal burr.
Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.
Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Radiofrequency electrosurgical cautery apparatus.

§886.4100
Radiofrequency electrosurgical cautery apparatus.
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
Classification. Class II.

Thermal cautery unit.

§886.4115
Thermal cautery unit.
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.
Classification. Class II.

Vitreous aspiration and cutting instrument.

§886.4150
Vitreous aspiration and cutting instrument.
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.
Classification. Class II.

Scleral plug.

§886.4155
Scleral plug.
Identification. A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery.
Classification. Class II (special controls). The special controls for the scleral plug are as follows: (1) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 886.9 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; and (iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device. (2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; (iii) Characterization of the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and (vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.

Cryophthalmic unit.

§886.4170
Cryophthalmic unit.
Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.
Classification. Class II.

Ophthalmic knife test drum.

§886.4230
Ophthalmic knife test drum.
Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic electrolysis unit.

§886.4250
Ophthalmic electrolysis unit.
Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.
Classification. Class I for the battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Intraocular gas.

§886.4270
Intraocular gas.
Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.
Classification. Class III.

Intraocular fluid.

§886.4275
Intraocular fluid.
Identification. An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
Classification. Class III.

Intraocular pressure measuring device.

§886.4280
Intraocular pressure measuring device.
Identification. An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.
Classification. Class III.

Intraocular lens guide.

§886.4300
Intraocular lens guide.
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Operating headlamp.

§886.4335
Operating headlamp.
Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.
Classification. Class I for the battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Manual ophthalmic surgical instrument.

§886.4350
Manual ophthalmic surgical instrument.
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ocular surgery irrigation device.

§886.4360
Ocular surgery irrigation device.
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Keratome.

§886.4370
Keratome.
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
Classification. Class I.

Ophthalmic laser.

§886.4390
Ophthalmic laser.
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
Classification. Class II.

Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.

§886.4392
Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
Identification. The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the invisible Nd:YAG laser radiation on or in close proximity to the target tissue.
Classification. Class II (special controls). Design Parameters: Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.

Electronic metal locator.

§886.4400
Electronic metal locator.
Identification. An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.
Classification. Class II.

AC-powered magnet.

§886.4440
AC-powered magnet.
Identification. An AC-powered magnet is an AC-powered device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.
Classification. Class II.

Permanent magnet.

§886.4445
Permanent magnet.
Identification. A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic surgical marker.

§886.4570
Ophthalmic surgical marker.
Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Ocular pressure applicator.

§886.4610
Ocular pressure applicator.
Identification. An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.
Classification. Class II.

Phacofragmentation system.

§886.4670
Phacofragmentation system.
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
Classification. Class II.

Ophthalmic photocoagulator.

§886.4690
Ophthalmic photocoagulator.
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.
Classification. Class II.

Ophthalmic eye shield.

§886.4750
Ophthalmic eye shield.
Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

Ophthalmic operating spectacles (loupes).

§886.4770
Ophthalmic operating spectacles (loupes).
Identification. Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic sponge.

§886.4790
Ophthalmic sponge.
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.
Classification. Class II.

Ophthalmic instrument table.

§886.4855
Ophthalmic instrument table.
Identification. An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.
Classification. Class I (general controls). The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic Therapeutic Devices

Ophthalmic Therapeutic Devices

Ophthalmic beta radiation source.

§886.5100
Ophthalmic beta radiation source.
Identification. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
Classification. Class II.

Low-power binocular loupe.

§886.5120
Low-power binocular loupe.
Identification. A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Eyelid thermal pulsation system.

§886.5200
Eyelid thermal pulsation system.
Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.
Classification. Class II (special controls). The special controls for this device are: (1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions; (3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (4) The device should be demonstrated to be biocompatible; and (5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.

Contact lens inserter/remover.

§886.5420
Contact lens inserter/remover.
Identification. A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Low-vision magnifier.

§886.5540
Low-vision magnifier.
Identification. A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ptosis crutch.

§886.5600
Ptosis crutch.
Identification. A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Eyelid weight.

§886.5700
Eyelid weight.
Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure). (1) The external eyelid weight is adhered to the outer skin of the upper eyelid. (2) The implantable eyelid weight is implanted into the upper eyelid.
Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 886.9. The special controls for the external eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; and (ii) Labeling must include the following information: (A) Specific instructions regarding the proper placement, sizing, and removal of the device; and (B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment. (2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; (ii) Testing demonstrating the sterility and shelf life of the device; (iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment. (iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.

Ophthalmic bar reader.

§886.5800
Ophthalmic bar reader.
Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ophthalmic prism reader.

§886.5810
Ophthalmic prism reader.
Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Closed-circuit television reading system.

§886.5820
Closed-circuit television reading system.
Identification. A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Nasolacrimal compression device.

§886.5838
Nasolacrimal compression device.
Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Magnifying spectacles.

§886.5840
Magnifying spectacles.
Identification. Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 866.9.

Spectacle frame.

§886.5842
Spectacle frame.
Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Prescription spectacle lens.

§886.5844
Prescription spectacle lens.
Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Sunglasses (nonprescription).

§886.5850
Sunglasses (nonprescription).
Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Low-vision telescope.

§886.5870
Low-vision telescope.
Identification. A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Electronic vision aid.

§886.5900
Electronic vision aid.
Identification. An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Oral electronic vision aid.

§886.5905
Oral electronic vision aid.
Identification. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog.
Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability. (3) Software verification, validation, and hazard analysis must be performed. (4) Analysis/testing must validate electromagnetic compatibility. (5) Analysis/testing must validate electrical safety. (6) Analysis/testing must assess and validate wireless coexistence concerns. (7) Any elements of the device that contact the patient must be demonstrated to be biocompatible. (8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use. (9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use).

Image intensification vision aid.

§886.5910
Image intensification vision aid.
Identification. An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Optical vision aid.

§886.5915
Optical vision aid.
Identification. An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.
Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Rigid gas permeable contact lens.

§886.5916
Rigid gas permeable contact lens.
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
Classification. (1) Class II if the device is intended for daily wear only. (2) Class III if the device is intended for extended wear.

Rigid gas permeable contact lens care products.

§886.5918
Rigid gas permeable contact lens care products.
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.
Classification. Class II (Special Controls) Guidance Document: Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.

Soft (hydrophilic) contact lens.

§886.5925
Soft (hydrophilic) contact lens.
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
Classification. (1) Class II if the device is intended for daily wear only. (2) Class III if the device is intended for extended wear.

Soft (hydrophilic) contact lens care products.

§886.5928
Soft (hydrophilic) contact lens care products.
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
Classification. Class II (Special Controls) Guidance Document: Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.