21 CFR Part 886
PART 886—OPHTHALMIC DEVICES
- PART 886—OPHTHALMIC DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- Subpart A—General Provisions
- § 886.1 Scope.
- § 886.3 Effective dates of requirement for premarket approval.
- § 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- Subpart B—Diagnostic Devices
- § 886.1040 Ocular esthesiometer.
- § 886.1050 Adaptometer (biophotometer).
- § 886.1070 Anomaloscope.
- § 886.1090 Haidinger brush.
- § 886.1100 Retinal diagnostic software device.
- § 886.1120 Ophthalmic camera.
- § 886.1140 Ophthalmic chair.
- § 886.1150 Visual acuity chart.
- § 886.1160 Color vision plate illuminator.
- § 886.1170 Color vision tester.
- § 886.1190 Distometer.
- § 886.1200 Optokinetic drum.
- § 886.1220 Corneal electrode.
- § 886.1250 Euthyscope.
- § 886.1270 Exophthalmometer.
- § 886.1290 Fixation device.
- § 886.1300 Afterimage flasher.
- § 886.1320 Fornixscope.
- § 886.1330 Amsler grid.
- § 886.1340 Haploscope.
- § 886.1342 Strabismus detection device.
- § 886.1350 Keratoscope.
- § 886.1360 Visual field laser instrument.
- § 886.1375 Bagolini lens.
- § 886.1380 Diagnostic condensing lens.
- § 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
- § 886.1390 Flexible diagnostic Fresnel lens.
- § 886.1395 Diagnostic Hruby fundus lens.
- § 886.1400 Maddox lens.
- § 886.1405 Ophthalmic trial lens set.
- § 886.1410 Ophthalmic trial lens clip.
- § 886.1415 Ophthalmic trial lens frame.
- § 886.1420 Ophthalmic lens gauge.
- § 886.1425 Lens measuring instrument.
- § 886.1430 Ophthalmic contact lens radius measuring device.
- § 886.1435 Maxwell spot.
- § 886.1450 Corneal radius measuring device.
- § 886.1460 Stereopsis measuring instrument.
- § 886.1500 Headband mirror.
- § 886.1510 Eye movement monitor.
- § 886.1570 Ophthalmoscope.
- § 886.1605 Perimeter.
- § 886.1630 AC-powered photostimulator.
- § 886.1640 Ophthalmic preamplifier.
- § 886.1650 Ophthalmic bar prism.
- § 886.1655 Ophthalmic Fresnel prism.
- § 886.1660 Gonioscopic prism.
- § 886.1665 Ophthalmic rotary prism.
- § 886.1670 Ophthalmic isotope uptake probe.
- § 886.1680 Ophthalmic projector.
- § 886.1690 Pupillograph.
- § 886.1700 Pupillometer.
- § 886.1750 Skiascopic rack.
- § 886.1760 Ophthalmic refractometer.
- § 886.1770 Manual refractor.
- § 886.1780 Retinoscope.
- § 886.1790 Nearpoint ruler.
- § 886.1800 Schirmer strip.
- § 886.1810 Tangent screen (campimeter).
- § 886.1840 Simulatan (including crossed cylinder).
- § 886.1850 AC-powered slitlamp biomicroscope.
- § 886.1860 Ophthalmic instrument stand.
- § 886.1870 Stereoscope.
- § 886.1880 Fusion and stereoscopic target.
- § 886.1905 Nystagmus tape.
- § 886.1910 Spectacle dissociation test system.
- § 886.1925 Diurnal pattern recorder system.
- § 886.1930 Tonometer and accessories.
- § 886.1940 Tonometer sterilizer.
- § 886.1945 Transilluminator.
- Subpart C [Reserved]
- Subpart D—Prosthetic Devices
- § 886.3100 Ophthalmic tantalum clip.
- § 886.3130 Ophthalmic conformer.
- § 886.3200 Artificial eye.
- § 886.3300 Absorbable implant (scleral buckling method).
- § 886.3320 Eye sphere implant.
- § 886.3340 Extraocular orbital implant.
- § 886.3400 Keratoprosthesis.
- § 886.3600 Intraocular lens.
- § 886.3800 Scleral shell.
- § 886.3920 Aqueous shunt.
- Subpart E—Surgical Devices
- § 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.
- § 886.4320 Corneal storage medium with preservatives including antifungals.
- § 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.
- Subpart F—Therapeutic Devices
- § 886.5100 Ophthalmic beta radiation source.
- § 886.5120 Low-power binocular loupe.
- § 886.5200 Eyelid thermal pulsation system.
- § 886.5201 Intense pulsed light device for managing dry eye.
- § 886.5300 Tear electrostimulation device.
- § 886.5305 Electromechanical tear stimulator.
- § 886.5310 Intranasal electrostimulation device for dry eye symptoms.
- § 886.5350 Ultrasound cyclodestructive device.
- § 886.5420 Contact lens inserter/remover.
- § 886.5500 Digital therapy device for amblyopia.
- § 886.5540 Low-vision magnifier.
- § 886.5600 Ptosis crutch.
- § 886.5700 Eyelid weight.
- § 886.5800 Ophthalmic bar reader. P>(a) 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.
- § 886.5810 Ophthalmic prism reader.
- § 886.5820 Closed-circuit television reading system.
- § 886.5838 Nasolacrimal compression device.
- § 886.5840 Magnifying spectacles.
- § 886.5842 Spectacle frame.
- § 886.5844 Prescription spectacle lens.
- § 886.5850 Sunglasses (nonprescription).
- § 886.5870 Low-vision telescope.
- § 886.5900 Electronic vision aid.
- § 886.5905 Oral electronic vision aid.
- § 886.5910 Image intensification vision aid.
- § 886.5915 Optical vision aid.
- § 886.5916 Rigid gas permeable contact lens.
- § 886.5918 Rigid gas permeable contact lens care products.
- § 886.5919 Hydrophilic re-coating solution.
- § 886.5925 Soft (hydrophilic) contact lens.
- § 886.5928 Soft (hydrophilic) contact lens care products.
- § 886.5933 [Reserved]
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