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Electronic Code of Federal Regulations

e-CFR data is current as of May 26, 2020

Title 21Chapter ISubchapter HPart 886 → Subpart E


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES


Subpart E—Surgical Devices


Contents
§886.4070   Powered corneal burr.
§886.4100   Radiofrequency electrosurgical cautery apparatus.
§886.4115   Thermal cautery unit.
§886.4150   Vitreous aspiration and cutting instrument.
§886.4155   Scleral plug.
§886.4170   Cryophthalmic unit.
§886.4230   Ophthalmic knife test drum.
§886.4250   Ophthalmic electrolysis unit.
§886.4270   Intraocular gas.
§886.4275   Intraocular fluid.
§886.4280   Intraocular pressure measuring device.
§886.4300   Intraocular lens guide.
§886.4335   Operating headlamp.
§886.4350   Manual ophthalmic surgical instrument.
§886.4355   Corneal inlay inserter handle.
§886.4360   Ocular surgery irrigation device.
§886.4370   Keratome.
§886.4390   Ophthalmic laser.
§886.4392   Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
§886.4400   Electronic metal locator.
§886.4440   AC-powered magnet.
§886.4445   Permanent magnet.
§886.4570   Ophthalmic surgical marker.
§886.4610   Ocular pressure applicator.
§886.4670   Phacofragmentation system.
§886.4690   Ophthalmic photocoagulator.
§886.4750   Ophthalmic eye shield.
§886.4770   Ophthalmic operating spectacles (loupes).
§886.4790   Ophthalmic sponge.
§886.4855   Ophthalmic instrument table.

§886.4070   Powered corneal burr.

(a) 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.

(b) 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.

[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2321, Jan. 14, 2000; 84 FR 71817, Dec. 30, 2019]

§886.4100   Radiofrequency electrosurgical cautery apparatus.

(a) 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.

(b) Classification. Class II.

§886.4115   Thermal cautery unit.

(a) 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.

(b) Classification. Class II.

§886.4150   Vitreous aspiration and cutting instrument.

(a) 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.

(b) Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]

§886.4155   Scleral plug.

(a) 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.

(b) 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.

[78 FR 68715, Nov. 15, 2013]

§886.4170   Cryophthalmic unit.

(a) 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.

(b) Classification. Class II.

§886.4230   Ophthalmic knife test drum.

(a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]

§886.4250   Ophthalmic electrolysis unit.

(a) 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.

(b) Classification. (1) Class I (general controls) 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.

(2) Class II (special controls) for the AC-powered device. The AC-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.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019]

§886.4270   Intraocular gas.

(a) 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.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See §886.3.

§886.4275   Intraocular fluid.

(a) 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.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See §886.3.

§886.4280   Intraocular pressure measuring device.

(a) 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.

(b) Classification. Class III.

(c) Date PMA or notice of completion of PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See §886.3.

§886.4300   Intraocular lens guide.

(a) 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.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]

§886.4335   Operating headlamp.

(a) 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.

(b) Classification. (1) Class I (general controls) 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.

(2) Class II (special controls) for the AC-powered device. The AC-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.

[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019]

§886.4350   Manual ophthalmic surgical instrument.

(a) 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.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 60 FR 15872, Mar. 28, 1995; 66 FR 38813, July 25, 2001]

§886.4355   Corneal inlay inserter handle.

(a) Identification. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.

(b) 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.CITA>[84 FR 14870, Apr. 12, 2019]

§886.4360   Ocular surgery irrigation device.

(a) 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.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]

§886.4370   Keratome.

(a) 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.

(b) Classification. Class I.

[55 FR 48443, Nov. 20, 1990]

§886.4390   Ophthalmic laser.

(a) 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.

(b) Classification. Class II.

§886.4392   Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.

(a) 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.

(b) 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.

[65 FR 6894, Feb. 11, 2000]

§886.4400   Electronic metal locator.

(a) Identification. An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.

(b) 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 the limitations in §886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]

§886.4440   AC-powered magnet.

(a) 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.

(b) 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 the limitations in §886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]

§886.4445   Permanent magnet.

(a) Identification. A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]

§886.4570   Ophthalmic surgical marker.

(a) 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.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]

§886.4610   Ocular pressure applicator.

(a) 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.

(b) Classification. Class II.

§886.4670   Phacofragmentation system.

(a) 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.

(b) Classification. Class II.

§886.4690   Ophthalmic photocoagulator.

(a) 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.

(b) Classification. Class II.

§886.4750   Ophthalmic eye shield.

(a) 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.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, 2000]

§886.4770   Ophthalmic operating spectacles (loupes).

(a) 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.

(b) 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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]

§886.4790   Ophthalmic sponge.

(a) 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.

(b) 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 the limitations in §886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]

§886.4855   Ophthalmic instrument table.

(a) Identification. An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.

(b) 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.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]

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