General & Plastic Surgery

General & Plastic Surgery

General and plastic surgery devices are utilized in the reconstructive and cosmetic surgery of patients. The FDA regulates these devices under CFR Title 21 Part 878, and the devices are categorized into four subparts.

Plastic Surgery Diagnostic Devices

Plastic Surgery Diagnostic Devices

Speculum and accessories.

§878.1800
Speculum and accessories.
Identification. A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.
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 878.9.

Plastic Surgery Prosthetic Devices

Plastic Surgery Prosthetic Devices

External facial fracture fixation appliance.

§878.3250
External facial fracture fixation appliance.
Identification. An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.
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 878.9.

Surgical mesh.

§878.3300
Surgical mesh.
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification. Class II.

Polytetrafluoroethylene with carbon fibers composite implant material

§878.3500
Polytetrafluoroethylene with carbon fibers composite implant material
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.
Classification. Class II.

Silicone inflatable breast prosthesis.

§878.3530
Silicone inflatable breast prosthesis.
Identification. A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.
Classification. Class III.

Silicone gel-filled breast prosthesis.

§878.3540
Silicone gel-filled breast prosthesis.
Identification(1) Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross-linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the female breast. (2) Double-lumen silicone gel-filled breast prosthesis. A double lumen silicone gel-filled breast prosthesis is a silicone rubber inner shell and a silicone rubber outer shell, both shells made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The inner shell contains fixed amounts of cross-linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast. (3) Polyurethane covered silicone gel-filled breast prosthesis. A polyurethane covered silicone gel-filled breast prosthesis is an inner silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross-linked polymerized silicone gel, fillers, and stabilizers and an inert support structure compartmentalizing the silicone gel. The device is intended to be implanted to augment or reconstruct the female breast.
Classification. Class III.

Chin prosthesis.

§878.3550
Chin prosthesis.
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.
Classification. Class II.

Ear prosthesis.

§878.3590
Ear prosthesis.
Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
Classification. Class II.

Esophageal prosthesis.

§878.3610
Esophageal prosthesis.
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
Classification. Class II. The special control for this device is FDA's Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.

Nose prosthesis.

§878.3680
Nose prosthesis.
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.
Classification. Class II.

Tracheal prosthesis.

§878.3720
Tracheal prosthesis.
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
Classification. Class II. The special control for this device is FDA's Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.

External prosthesis adhesive.

§878.3750
External prosthesis adhesive.
Identification. An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.
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 878.9.

External aesthetic restoration prosthesis.

§878.3800
External aesthetic restoration prosthesis.
Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. 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 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the 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, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Inflatable extremity splint.

§878.3900
Inflatable extremity splint.
Identification. An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.
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 878.9.

Noninflatable extremity splint.

§878.3910
Noninflatable extremity splint.
Identification. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
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 878.9. If the device is not labeled or otherwise represented as sterile, it 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.

Plastic surgery kit and accessories.

§878.3925
Plastic surgery kit and accessories.
Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.
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 878.9.

Plastic Surgery Surgical Devices

Plastic Surgery Surgical Devices

Tissue adhesive.

§878.4010
Tissue adhesive.
Tissue adhesive for the topical approximation of skin(1) Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches. (2) Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. See 878.1(e) of this chapter for the availability of this guidance document.
Tissue adhesive for non-topical use(1) Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels. (2) Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 878.3 of this chapter.

Tissue adhesive with adjunct wound closure device for topical

§878.4011
Tissue adhesive with adjunct wound closure device for topical
Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.
Classification. Class II (special controls). The special control for this device is FDA's Guidance for Industry and FDA Staff

Nonresorbable gauze/sponge for external use.

§878.4014
Nonresorbable gauze/sponge for external use.
Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in 878.9.

Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive chloride)

§878.4015
Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive chloride)
Identification. A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.
Classification. Class II (special controls). The special control is: the FDA guidance document entitled Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive. See 878.1(e) for availability of this guidance document.

Hydrophilic wound dressing.

§878.4018
Hydrophilic wound dressing.
Identification. A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in 878.9.

Occlusive wound dressing.

§878.4020
Occlusive wound dressing.
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in 878.9.

Hydrogel wound dressing and burn dressing.

§878.4022
Hydrogel wound dressing and burn dressing.
Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in 878.9.

Silicone sheeting.

§878.4025
Silicone sheeting.
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
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 878.9.

Surgical apparel.

§878.4040
Surgical apparel.
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

Organ bag.

§878.4100
Organ bag.
Identification. An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.
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 878.9.

Surgical camera and accessories.

§878.4160
Surgical camera and accessories.
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.
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 878.9.

Introduction/drainage catheter and accessories.

§878.4200
Introduction/drainage catheter and accessories.
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
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 878.9.

Implantable clip.

§878.4300
Implantable clip.
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification. Class II.

Removable skin clip.

§878.4320
Removable skin clip.
Identification. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.
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 878.9.

Contact cooling system for aesthetic use.

§878.4340
Contact cooling system for aesthetic use.
Identification. A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.
Classification. Class II (special controls). The special controls for this device is FDA's Guidance for Industry and FDA Staff

Cryosurgical unit and accessories.

§878.4350
Cryosurgical unit and accessories.
Identification(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.
Classification. Class II.

Scalp cooling system to reduce the likelihood of chemotherapy

§878.4360
Scalp cooling system to reduce the likelihood of chemotherapy
Identification. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
ClassificationClass II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism. (2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device. (3) Software verification, validation, and hazard analysis must be performed. (4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided. (5) Labeling must include the following: (i) A statement describing the potential risk of developing scalp metastasis. (ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective. (iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device. (iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling. (v) A summary of the device- and procedure-related adverse events pertinent to use of the device. (vi) Information on how the device operates and the typical course of treatment. (6) Patient labeling must be provided and must include: (i) Relevant contraindications, warnings, precautions, and adverse effects/complications. (ii) Information on how the device operates and the typical course of treatment. (iii) Information on the patient population for which there is clinical evidence of effectiveness. (iv) The potential risks and benefits associated with use of the device. (v) Postoperative care instructions. (vi) A statement describing the potential risk of developing scalp metastasis.

Surgical drape and drape accessories.

§878.4370
Surgical drape and drape accessories.
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
Classification. Class II.

Drape adhesive.

§878.4380
Drape adhesive.
Identification. A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
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 878.9.

Electrosurgical cutting and coagulation device and accessories

§878.4400
Electrosurgical cutting and coagulation device and accessories
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification. Class II.

Low energy ultrasound wound cleaner.

§878.4410
Low energy ultrasound wound cleaner.
Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.
Classification. Class II (special controls). The special control is FDA's guidance document entitled Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner. See 878.1(e) for the availability of this guidance document.

Electrosurgical device for over-the-counter aesthetic use.

§878.4420
Electrosurgical device for over-the-counter aesthetic use.
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters. (2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use. (3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use. (4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Instructions for cleaning the device must be validated. (7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Labeling must include: (i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users. (ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known. (iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.

Eye pad.

§878.4440
Eye pad.
Identification. An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.
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 878.9.

Nonabsorbable gauze for internal use.

§878.4450
Nonabsorbable gauze for internal use.
Identification. Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.
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 878.9.

Nonabsorbable expandable hemostatic sponge for temporary internal use

§878.4452
Nonabsorbable expandable hemostatic sponge for temporary internal use
Identification. A nonabsorbable expandable hemostatic sponge for temporary internal use is a prescription device intended to be placed temporarily into junctional, non-compressible wounds, which are not amenable to tourniquet use, to control bleeding until surgical care is acquired. The sponges expand upon contact with blood to fill the wound cavity and provide a physical barrier and pressure that facilitates formation of a clot. The device consists of sterile, nonabsorbable radiopaque compressed sponges and may include an applicator to facilitate delivery into a wound.
Classification. Class II (special controls). The special controls for this device are: (1) Performance data must demonstrate the biocompatibility of patient-contacting components. (2) Performance data must demonstrate the sterility of patient-contacting components including endotoxin and pyrogenicity assessments. (3) Performance data must support device stability by demonstrating continued sterility of the patient-contacting components of the device, package integrity, and device functionality over the requested shelf life. (4) Assessment of material characteristics must be sufficient to support safety under anticipated conditions of use. Assessments must include the following: (i) Material specifications. (ii) Immunogenicity. (iii) Viral inactivation for animal-derived materials. (5) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Absorption capacity. (ii) Extent of swelling. (iii) Mechanical properties. (iv) Expansion force/pressure. (v) Radiopacity. (vi) Deployment/applicator functionality. (6) In vivo performance data must demonstrate safe and effective use by verifying that the device performs as intended under anticipated conditions of use. Appropriate analysis/testing must demonstrate that the product: Controls bleeding, does not promote adverse local or systemic effects, and can be completely removed from the wound. The following performance characteristics must be tested: (i) Deployment. (ii) Control of bleeding. (iii) Radiopacity. (iv) Retrieval. (v) Assessment of local and systemic effects. (7) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by emergency responders deploying the device as well as surgeons retrieving the device from wounds. (8) Labeling must include: (i) Specific instructions for deployment by emergency responders and retrieval by surgeons. (ii) Warnings, cautions, and limitations needed for safe use of the device. (iii) Information on how the device operates and the typical course of treatment. (iv) A detailed summary of the in vivo and human factors testing pertinent to use of the device. (v) Appropriate imaging information to ensure complete retrieval of device. (vi) An expiration date/shelf life.

Non-powdered surgeon's glove.

§878.4460
Non-powdered surgeon's glove.
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification. Class I (general controls).

Surgeon's gloving cream.

§878.4470
Surgeon's gloving cream.
Identification. Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove.
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 878.9.

Absorbable hemostatic agent and dressing.

§878.4490
Absorbable hemostatic agent and dressing.
Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.
Classification. Class III.

Absorbable poly(glycolide/l-lactide) surgical suture.

§878.4493
Absorbable poly(glycolide/l-lactide) surgical suture.
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Absorbable Surgical Sutures; it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Absorbable poly(hydroxybutyrate) surgical suture produced by recombinanat DNA technology

§878.4494
Absorbable poly(hydroxybutyrate) surgical suture produced by recombinanat DNA technology
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology. For the availability of this guidance document see 878.1(e).

Stainless steel suture.

§878.4495
Stainless steel suture.
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Polytetrafluoroethylene injectable.

§878.4520
Polytetrafluoroethylene injectable.
Identification. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.
Classification. Class III.

Surgical lamp.

§878.4580
Surgical lamp.
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Classification. Class II.

Focused ultrasound stimulator system for aesthetic use.

§878.4590
Focused ultrasound stimulator system for aesthetic use.
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use. See 878.1(e) for the availability of this guidance document.

Ultraviolet lamp for dermatologic disorders.

§878.4630
Ultraviolet lamp for dermatologic disorders.
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.
Classification. Class II.

Sunlamp products and ultraviolet lamps intended for use in sunlamp products

§878.4635
Sunlamp products and ultraviolet lamps intended for use in sunlamp products
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are: (1) Conduct performance testing that demonstrates the following: (i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and (ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly. (2) Demonstrate that device is mechanically safe to prevent user injury. (3) Demonstrate software verification, validation, and hazard analysis. (4) Demonstrate that device is biocompatible. (5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment. (6) Labeling(i) Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions. (ii) Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements: (A) Contraindication: This product is contraindicated for use on persons under the age of 18 years. (B) Contraindication: This product must not be used if skin lesions or open wounds are present. (C) Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer. (D) Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer. (c) Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at 1040.20 of this chapter.

Skin marker.

§878.4660
Skin marker.
Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.
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 878.9.

Internal tissue marker.

§878.4670
Internal tissue marker.
Identification. An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
Classification. Class II (special controls). The special controls for this device are: (1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. (2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated. (3) Performance data must demonstrate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life. (5) Labeling must include: (i) A warning that the device must not be used on a non-sterile surface prior to use internally. (ii) An expiration date/shelf life. (iii) Single use only labeling must be labeled directly on the device.

Nonpowered, single patient, portable suction apparatus.

§878.4680
Nonpowered, single patient, portable suction apparatus.
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.
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 878.9.

Non-Powered suction apparatus device intended for negative pressure wound therapy

§878.4683
Non-Powered suction apparatus device intended for negative pressure wound therapy
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT). See 878.1(e) for the availability of this guidance document.

Surgical microscope and accessories.

§878.4700
Surgical microscope and accessories.
Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of 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 878.9.

Surgical skin degreaser or adhesive tape solvent.

§878.4730
Surgical skin degreaser or adhesive tape solvent.
Identification. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
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 878.9.

Implantable staple.

§878.4750
Implantable staple.
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification. Class II.

Absorbable lung biopsy plug.

§878.4755
Absorbable lung biopsy plug.
Identification. A preformed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.
Classification. Class II (special controls). The special controls for this device are: (1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use. (2) Performance testing must demonstrate deployment as indicated in the accompanying labeling, including the indicated introducer needles, and demonstrate expansion and resorption characteristics in a clinically relevant environment. (3) In vivo evaluation must demonstrate performance characteristics of the device, including the ability of the plug to not prematurely resorb or migrate and the rate of pneumothorax. (4) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the plug. (5) Shelf-life testing must demonstrate the shelf-life of the device including the physical characteristics of the plug. (6) The device must be demonstrated to be biocompatible. (7) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device and appropriate warnings. Labeling must include identification of compatible introducer needles.

Removable skin staple.

§878.4760
Removable skin staple.
Identification. A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.
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 878.9.

Powered suction pump.

§878.4780
Powered suction pump.
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Classification. Class II.

Powered surgical instrument for improvement in the appearance of cellulite

§878.4790
Powered surgical instrument for improvement in the appearance of cellulite
Identification. A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.
Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device. (2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites. (3) All elements of the device that may contact the patient must be demonstrated to be biocompatible. (4) Electrical safety and electromagnetic compatibility of the device must be demonstrated. (5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications. (6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.

Manual surgical instrument for general use.

§878.4800
Manual surgical instrument for general use.
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
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 878.9.

Laser surgical instrument for use in general and plastic surgery and dermatology

§878.4810
Laser surgical instrument for use in general and plastic surgery and dermatology
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. (2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification. (1) Class II. (2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

Magnetic surgical instrument system.

§878.4815
Magnetic surgical instrument system.
Identification. A magnetic surgical instrument system is a prescription device used in laparoscopic surgical procedures consisting of several components, such as surgical instruments, and a magnetic controller. The magnetic controller is provided separately from the surgical instrument and is used outside the patient. The external magnetic controller is magnetically coupled with the internal surgical instrument(s) at the surgical site to grasp, hold, retract, mobilize, or manipulate soft tissue and organs.
Classification. Class II (special controls). The special controls for this device are: (1) In vivo performance data must demonstrate that the device performs as intended under anticipated conditions of use. Testing must demonstrate the ability of the device to grasp, hold, retract, mobilize, or manipulate soft tissue and organs. (2) Non-clinical performance data must demonstrate that the system performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic field strength testing characterization to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects. (ii) Ability of the internal surgical instrument(s) to be coupled, de-coupled, and re-coupled with the external magnet over the external magnet use life. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components that are patient-contacting. (5) Methods and instructions for reprocessing reusable components must be validated. (6) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components and device functionality over the labeled shelf life. (7) Training must be developed and validated by human factors testing and analysis to ensure users can follow the instructions for use to allow safe use of the device. (8) Labeling must include: (i) Magnetic field safe zones. (ii) Instructions for proper device use. (iii) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet. (iv) Reprocessing instructions for any reusable components. (v) Shelf life. (vi) Use life.

Surgical instrument motors and accessories/attachments.

§878.4820
Surgical instrument motors and accessories/attachments.
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
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 878.9.

Absorbable surgical gut suture.

§878.4830
Absorbable surgical gut suture.
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Absorbable polydioxanone surgical suture.

§878.4840
Absorbable polydioxanone surgical suture.
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.
Classification. Class II (special controls). The special control for the device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Suture retention device.

§878.4930
Suture retention device.
Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in 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 878.9.

Manual operating table and accessories and manual operating chair and accessories

§878.4950
Manual operating table and accessories and manual operating chair and accessories
Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
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 878.9.

Operating tables and accessories and operating chairs and accessories

§878.4960
Operating tables and accessories and operating chairs and accessories
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a 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 878.9.

Nonabsorbable poly(ethylene terephthalate) surgical suture.

§878.5000
Nonabsorbable poly(ethylene terephthalate) surgical suture.
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Nonabsorbable polypropylene surgical suture.

§878.5010
Nonabsorbable polypropylene surgical suture.
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Nonabsorbable polyamide surgical suture.

§878.5020
Nonabsorbable polyamide surgical suture.
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Natural nonabsorbable silk surgical suture.

§878.5030
Natural nonabsorbable silk surgical suture.
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Nonabsorbable expanded polytetrafluoroethylene surgical suture

§878.5035
Nonabsorbable expanded polytetrafluoroethylene surgical suture
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance Document: Surgical Sutures

Suction lipoplasty system.

§878.5040
Suction lipoplasty system.
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 13 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.
Classification. Class II (special controls). Consensus standards and labeling restrictions.

Plastic Surgery Therapeutic Devices

Plastic Surgery Therapeutic Devices

Air-handling apparatus for a surgical operating room.

§878.5070
Air-handling apparatus for a surgical operating room.
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.
Classification. Class II.

Needle-type epilator.

§878.5350
Needle-type epilator.
Identification. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.
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 878.9.

Tweezer-type epilator.

§878.5360
Tweezer-type epilator.
Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.
Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

Low level laser system for aesthetic use

§878.5400
Low level laser system for aesthetic use
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Guidance for Industry and Food and Drug Administration Staff

Topical oxygen chamber for extremities.

§878.5650
Topical oxygen chamber for extremities.
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.
Classification. Class II (special controls). The special control for this device is FDA's Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities. See 878.1(e) for the availability of this guidance document.

Nonpneumatic tourniquet.

§878.5900
Nonpneumatic tourniquet.
Identification. A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.
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 878.9.

Pneumatic tourniquet.

§878.5910
Pneumatic tourniquet.
Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during 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 878.9.