TITLE 21--FOOD AND DRUGS 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.
§ 886.4335 - 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.
§ 886.5420 - Contact lens inserter/remover.
§ 886.5540 - Low-vision magnifier.
§ 886.5600 - Ptosis crutch.
§ 886.5700 - Eyelid weight.
§ 886.5800 - Ophthalmic bar reader.
§ 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.
§ 886.5925 - Soft (hydrophilic) contact lens.
§ 886.5928 - Soft (hydrophilic) contact lens care products.
§ 886.5933 - [Reserved]
| 
