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Title 21 - Title 21
Part 886 - OPHTHALMIC DEVICES
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Details about Part 886
Description
MEDICAL DEVICES - OPHTHALMIC DEVICES
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138 sections
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§886.1 - Scope.
Title 21, Part 886
§886.1040 - Ocular esthesiometer.
Title 21, Part 886
§886.1050 - Adaptometer (biophotometer).
Title 21, Part 886
§886.1070 - Anomaloscope.
Title 21, Part 886
§886.1090 - Haidinger brush.
Title 21, Part 886
§886.1120 - Ophthalmic camera.
Title 21, Part 886
§886.1140 - Ophthalmic chair.
Title 21, Part 886
§886.1150 - Visual acuity chart.
Title 21, Part 886
§886.1160 - Color vision plate illuminator.
Title 21, Part 886
§886.1170 - Color vision tester.
Title 21, Part 886
§886.1190 - Distometer.
Title 21, Part 886
§886.1200 - Optokinetic drum.
Title 21, Part 886
§886.1220 - Corneal electrode.
Title 21, Part 886
§886.1250 - Euthyscope.
Title 21, Part 886
§886.1270 - Exophthalmometer.
Title 21, Part 886
§886.1290 - Fixation device.
Title 21, Part 886
§886.1300 - Afterimage flasher.
Title 21, Part 886
§886.1320 - Fornixscope.
Title 21, Part 886
§886.1330 - Amsler grid.
Title 21, Part 886
§886.1340 - Haploscope.
Title 21, Part 886
§886.1342 - Strabismus detection device.
Title 21, Part 886
§886.1350 - Keratoscope.
Title 21, Part 886
§886.1360 - Visual field laser instrument.
Title 21, Part 886
§886.1375 - Bagolini lens.
Title 21, Part 886
§886.1380 - Diagnostic condensing lens.
Title 21, Part 886
§886.1385 - Polymethylmethacrylate (PMMA) diagnostic contact lens.
Title 21, Part 886
§886.1390 - Flexible diagnostic Fresnel lens.
Title 21, Part 886
§886.1395 - Diagnostic Hruby fundus lens.
Title 21, Part 886
§886.1400 - Maddox lens.
Title 21, Part 886
§886.1405 - Ophthalmic trial lens set.
Title 21, Part 886
§886.1410 - Ophthalmic trial lens clip.
Title 21, Part 886
§886.1415 - Ophthalmic trial lens frame.
Title 21, Part 886
§886.1420 - Ophthalmic lens gauge.
Title 21, Part 886
§886.1425 - Lens measuring instrument.
Title 21, Part 886
§886.1430 - Ophthalmic contact lens radius measuring device.
Title 21, Part 886
§886.1435 - Maxwell spot.
Title 21, Part 886
§886.1450 - Corneal radius measuring device.
Title 21, Part 886
§886.1460 - Stereopsis measuring instrument.
Title 21, Part 886
§886.1500 - Headband mirror.
Title 21, Part 886
§886.1510 - Eye movement monitor.
Title 21, Part 886
§886.1570 - Ophthalmoscope.
Title 21, Part 886
§886.1605 - Perimeter.
Title 21, Part 886
§886.1630 - AC-powered photostimulator.
Title 21, Part 886
§886.1640 - Ophthalmic preamplifier.
Title 21, Part 886
§886.1650 - Ophthalmic bar prism.
Title 21, Part 886
§886.1655 - Ophthalmic Fresnel prism.
Title 21, Part 886
§886.1660 - Gonioscopic prism.
Title 21, Part 886
§886.1665 - Ophthalmic rotary prism.
Title 21, Part 886
§886.1670 - Ophthalmic isotope uptake probe.
Title 21, Part 886
§886.1680 - Ophthalmic projector.
Title 21, Part 886
§886.1690 - Pupillograph.
Title 21, Part 886
§886.1700 - Pupillometer.
Title 21, Part 886
§886.1750 - Skiascopic rack.
Title 21, Part 886
§886.1760 - Ophthalmic refractometer.
Title 21, Part 886
§886.1770 - Manual refractor.
Title 21, Part 886
§886.1780 - Retinoscope.
Title 21, Part 886
§886.1790 - Nearpoint ruler.
Title 21, Part 886
§886.1800 - Schirmer strip.
Title 21, Part 886
§886.1810 - Tangent screen (campimeter).
Title 21, Part 886
§886.1840 - Simulatan (including crossed cylinder).
Title 21, Part 886
§886.1850 - AC-powered slitlamp biomicroscope.
Title 21, Part 886
§886.1860 - Ophthalmic instrument stand.
Title 21, Part 886
§886.1870 - Stereoscope.
Title 21, Part 886
§886.1880 - Fusion and stereoscopic target.
Title 21, Part 886
§886.1905 - Nystagmus tape.
Title 21, Part 886
§886.1910 - Spectacle dissociation test system.
Title 21, Part 886
§886.1925 - Diurnal pattern recorder system.
Title 21, Part 886
§886.1930 - Tonometer and accessories.
Title 21, Part 886
§886.1940 - Tonometer sterilizer.
Title 21, Part 886
§886.1945 - Transilluminator.
Title 21, Part 886
§886.3 - Effective dates of requirement for premarket approval.
Title 21, Part 886
§886.3100 - Ophthalmic tantalum clip.
Title 21, Part 886
§886.3130 - Ophthalmic conformer.
Title 21, Part 886
§886.3200 - Artificial eye.
Title 21, Part 886
§886.3300 - Absorbable implant (scleral buckling method).
Title 21, Part 886
§886.3320 - Eye sphere implant.
Title 21, Part 886
§886.3340 - Extraocular orbital implant.
Title 21, Part 886
§886.3400 - Keratoprosthesis.
Title 21, Part 886
§886.3600 - Intraocular lens.
Title 21, Part 886
§886.3800 - Scleral shell.
Title 21, Part 886
§886.3920 - Aqueous shunt.
Title 21, Part 886
§886.4070 - Powered corneal burr.
Title 21, Part 886
§886.4100 - Radiofrequency electrosurgical cautery apparatus.
Title 21, Part 886
§886.4115 - Thermal cautery unit.
Title 21, Part 886
§886.4150 - Vitreous aspiration and cutting instrument.
Title 21, Part 886
§886.4155 - Scleral plug.
Title 21, Part 886
§886.4170 - Cryophthalmic unit.
Title 21, Part 886
§886.4230 - Ophthalmic knife test drum.
Title 21, Part 886
§886.4250 - Ophthalmic electrolysis unit.
Title 21, Part 886
§886.4270 - Intraocular gas.
Title 21, Part 886
§886.4275 - Intraocular fluid.
Title 21, Part 886
§886.4280 - Intraocular pressure measuring device.
Title 21, Part 886
§886.4300 - Intraocular lens guide.
Title 21, Part 886
§886.4335 - Operating headlamp.
Title 21, Part 886
§886.4350 - Manual ophthalmic surgical instrument.
Title 21, Part 886
§886.4360 - Ocular surgery irrigation device.
Title 21, Part 886
§886.4370 - Keratome.
Title 21, Part 886
§886.4390 - Ophthalmic laser.
Title 21, Part 886
§886.4392 - Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
Title 21, Part 886
§886.4400 - Electronic metal locator.
Title 21, Part 886
§886.4440 - AC-powered magnet.
Title 21, Part 886
§886.4445 - Permanent magnet.
Title 21, Part 886
§886.4570 - Ophthalmic surgical marker.
Title 21, Part 886
§886.4610 - Ocular pressure applicator.
Title 21, Part 886
§886.4670 - Phacofragmentation system.
Title 21, Part 886
§886.4690 - Ophthalmic photocoagulator.
Title 21, Part 886
§886.4750 - Ophthalmic eye shield.
Title 21, Part 886
§886.4770 - Ophthalmic operating spectacles (loupes).
Title 21, Part 886
§886.4790 - Ophthalmic sponge.
Title 21, Part 886
§886.4855 - Ophthalmic instrument table.
Title 21, Part 886
§886.5100 - Ophthalmic beta radiation source.
Title 21, Part 886
§886.5120 - Low-power binocular loupe.
Title 21, Part 886
§886.5200 - Eyelid thermal pulsation system.
Title 21, Part 886
§886.5300 - Tear electrostimulation device.
Title 21, Part 886
§886.5310 - Intranasal electrostimulation device for dry eye symptoms.
Title 21, Part 886
§886.5420 - Contact lens inserter/remover.
Title 21, Part 886
§886.5540 - Low-vision magnifier.
Title 21, Part 886
§886.5600 - Ptosis crutch.
Title 21, Part 886
§886.5700 - Eyelid weight.
Title 21, Part 886
§886.5800 - Ophthalmic bar reader.
Title 21, Part 886
§886.5810 - Ophthalmic prism reader.
Title 21, Part 886
§886.5820 - Closed-circuit television reading system.
Title 21, Part 886
§886.5838 - Nasolacrimal compression device.
Title 21, Part 886
§886.5840 - Magnifying spectacles.
Title 21, Part 886
§886.5842 - Spectacle frame.
Title 21, Part 886
§886.5844 - Prescription spectacle lens.
Title 21, Part 886
§886.5850 - Sunglasses (nonprescription).
Title 21, Part 886
§886.5870 - Low-vision telescope.
Title 21, Part 886
§886.5900 - Electronic vision aid.
Title 21, Part 886
§886.5905 - Oral electronic vision aid.
Title 21, Part 886
§886.5910 - Image intensification vision aid.
Title 21, Part 886
§886.5915 - Optical vision aid.
Title 21, Part 886
§886.5916 - Rigid gas permeable contact lens.
Title 21, Part 886
§886.5918 - Rigid gas permeable contact lens care products.
Title 21, Part 886
§886.5925 - Soft (hydrophilic) contact lens.
Title 21, Part 886
§886.5928 - Soft (hydrophilic) contact lens care products.
Title 21, Part 886
§886.5933 - Unknown
Title 21, Part 886
§886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Title 21, Part 886