Title 21

PART 886

Part 886 - Ophthalmic Devices

PART 886 - OPHTHALMIC DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:52 FR 33355, Sept. 2, 1987, unless otherwise noted. Editorial Note:Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.30.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.30.1.1.1SECTION 886.1
   886.1 Scope.
21:8.0.1.1.30.1.1.2SECTION 886.3
   886.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.30.1.1.3SECTION 886.9
   886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.30.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.30.2.1.1SECTION 886.1040
   886.1040 Ocular esthesiometer.
21:8.0.1.1.30.2.1.2SECTION 886.1050
   886.1050 Adaptometer (biophotometer).
21:8.0.1.1.30.2.1.3SECTION 886.1070
   886.1070 Anomaloscope.
21:8.0.1.1.30.2.1.4SECTION 886.1090
   886.1090 Haidinger brush.
21:8.0.1.1.30.2.1.5SECTION 886.1120
   886.1120 Ophthalmic camera.
21:8.0.1.1.30.2.1.6SECTION 886.1140
   886.1140 Ophthalmic chair.
21:8.0.1.1.30.2.1.7SECTION 886.1150
   886.1150 Visual acuity chart.
21:8.0.1.1.30.2.1.8SECTION 886.1160
   886.1160 Color vision plate illuminator.
21:8.0.1.1.30.2.1.9SECTION 886.1170
   886.1170 Color vision tester.
21:8.0.1.1.30.2.1.10SECTION 886.1190
   886.1190 Distometer.
21:8.0.1.1.30.2.1.11SECTION 886.1200
   886.1200 Optokinetic drum.
21:8.0.1.1.30.2.1.12SECTION 886.1220
   886.1220 Corneal electrode.
21:8.0.1.1.30.2.1.13SECTION 886.1250
   886.1250 Euthyscope.
21:8.0.1.1.30.2.1.14SECTION 886.1270
   886.1270 Exophthalmometer.
21:8.0.1.1.30.2.1.15SECTION 886.1290
   886.1290 Fixation device.
21:8.0.1.1.30.2.1.16SECTION 886.1300
   886.1300 Afterimage flasher.
21:8.0.1.1.30.2.1.17SECTION 886.1320
   886.1320 Fornixscope.
21:8.0.1.1.30.2.1.18SECTION 886.1330
   886.1330 Amsler grid.
21:8.0.1.1.30.2.1.19SECTION 886.1340
   886.1340 Haploscope.
21:8.0.1.1.30.2.1.20SECTION 886.1342
   886.1342 Strabismus detection device.
21:8.0.1.1.30.2.1.21SECTION 886.1350
   886.1350 Keratoscope.
21:8.0.1.1.30.2.1.22SECTION 886.1360
   886.1360 Visual field laser instrument.
21:8.0.1.1.30.2.1.23SECTION 886.1375
   886.1375 Bagolini lens.
21:8.0.1.1.30.2.1.24SECTION 886.1380
   886.1380 Diagnostic condensing lens.
21:8.0.1.1.30.2.1.25SECTION 886.1385
   886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
21:8.0.1.1.30.2.1.26SECTION 886.1390
   886.1390 Flexible diagnostic Fresnel lens.
21:8.0.1.1.30.2.1.27SECTION 886.1395
   886.1395 Diagnostic Hruby fundus lens.
21:8.0.1.1.30.2.1.28SECTION 886.1400
   886.1400 Maddox lens.
21:8.0.1.1.30.2.1.29SECTION 886.1405
   886.1405 Ophthalmic trial lens set.
21:8.0.1.1.30.2.1.30SECTION 886.1410
   886.1410 Ophthalmic trial lens clip.
21:8.0.1.1.30.2.1.31SECTION 886.1415
   886.1415 Ophthalmic trial lens frame.
21:8.0.1.1.30.2.1.32SECTION 886.1420
   886.1420 Ophthalmic lens gauge.
21:8.0.1.1.30.2.1.33SECTION 886.1425
   886.1425 Lens measuring instrument.
21:8.0.1.1.30.2.1.34SECTION 886.1430
   886.1430 Ophthalmic contact lens radius measuring device.
21:8.0.1.1.30.2.1.35SECTION 886.1435
   886.1435 Maxwell spot.
21:8.0.1.1.30.2.1.36SECTION 886.1450
   886.1450 Corneal radius measuring device.
21:8.0.1.1.30.2.1.37SECTION 886.1460
   886.1460 Stereopsis measuring instrument.
21:8.0.1.1.30.2.1.38SECTION 886.1500
   886.1500 Headband mirror.
21:8.0.1.1.30.2.1.39SECTION 886.1510
   886.1510 Eye movement monitor.
21:8.0.1.1.30.2.1.40SECTION 886.1570
   886.1570 Ophthalmoscope.
21:8.0.1.1.30.2.1.41SECTION 886.1605
   886.1605 Perimeter.
21:8.0.1.1.30.2.1.42SECTION 886.1630
   886.1630 AC-powered photostimulator.
21:8.0.1.1.30.2.1.43SECTION 886.1640
   886.1640 Ophthalmic preamplifier.
21:8.0.1.1.30.2.1.44SECTION 886.1650
   886.1650 Ophthalmic bar prism.
21:8.0.1.1.30.2.1.45SECTION 886.1655
   886.1655 Ophthalmic Fresnel prism.
21:8.0.1.1.30.2.1.46SECTION 886.1660
   886.1660 Gonioscopic prism.
21:8.0.1.1.30.2.1.47SECTION 886.1665
   886.1665 Ophthalmic rotary prism.
21:8.0.1.1.30.2.1.48SECTION 886.1670
   886.1670 Ophthalmic isotope uptake probe.
21:8.0.1.1.30.2.1.49SECTION 886.1680
   886.1680 Ophthalmic projector.
21:8.0.1.1.30.2.1.50SECTION 886.1690
   886.1690 Pupillograph.
21:8.0.1.1.30.2.1.51SECTION 886.1700
   886.1700 Pupillometer.
21:8.0.1.1.30.2.1.52SECTION 886.1750
   886.1750 Skiascopic rack.
21:8.0.1.1.30.2.1.53SECTION 886.1760
   886.1760 Ophthalmic refractometer.
21:8.0.1.1.30.2.1.54SECTION 886.1770
   886.1770 Manual refractor.
21:8.0.1.1.30.2.1.55SECTION 886.1780
   886.1780 Retinoscope.
21:8.0.1.1.30.2.1.56SECTION 886.1790
   886.1790 Nearpoint ruler.
21:8.0.1.1.30.2.1.57SECTION 886.1800
   886.1800 Schirmer strip.
21:8.0.1.1.30.2.1.58SECTION 886.1810
   886.1810 Tangent screen (campimeter).
21:8.0.1.1.30.2.1.59SECTION 886.1840
   886.1840 Simulatan (including crossed cylinder).
21:8.0.1.1.30.2.1.60SECTION 886.1850
   886.1850 AC-powered slitlamp biomicroscope.
21:8.0.1.1.30.2.1.61SECTION 886.1860
   886.1860 Ophthalmic instrument stand.
21:8.0.1.1.30.2.1.62SECTION 886.1870
   886.1870 Stereoscope.
21:8.0.1.1.30.2.1.63SECTION 886.1880
   886.1880 Fusion and stereoscopic target.
21:8.0.1.1.30.2.1.64SECTION 886.1905
   886.1905 Nystagmus tape.
21:8.0.1.1.30.2.1.65SECTION 886.1910
   886.1910 Spectacle dissociation test system.
21:8.0.1.1.30.2.1.66SECTION 886.1925
   886.1925 Diurnal pattern recorder system.
21:8.0.1.1.30.2.1.67SECTION 886.1930
   886.1930 Tonometer and accessories.
21:8.0.1.1.30.2.1.68SECTION 886.1940
   886.1940 Tonometer sterilizer.
21:8.0.1.1.30.2.1.69SECTION 886.1945
   886.1945 Transilluminator.
21:8.0.1.1.30.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.30.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.30.4.1.1SECTION 886.3100
   886.3100 Ophthalmic tantalum clip.
21:8.0.1.1.30.4.1.2SECTION 886.3130
   886.3130 Ophthalmic conformer.
21:8.0.1.1.30.4.1.3SECTION 886.3200
   886.3200 Artificial eye.
21:8.0.1.1.30.4.1.4SECTION 886.3300
   886.3300 Absorbable implant (scleral buckling method).
21:8.0.1.1.30.4.1.5SECTION 886.3320
   886.3320 Eye sphere implant.
21:8.0.1.1.30.4.1.6SECTION 886.3340
   886.3340 Extraocular orbital implant.
21:8.0.1.1.30.4.1.7SECTION 886.3400
   886.3400 Keratoprosthesis.
21:8.0.1.1.30.4.1.8SECTION 886.3600
   886.3600 Intraocular lens.
21:8.0.1.1.30.4.1.9SECTION 886.3800
   886.3800 Scleral shell.
21:8.0.1.1.30.4.1.10SECTION 886.3920
   886.3920 Aqueous shunt.
21:8.0.1.1.30.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.30.5.1.1SECTION 886.4070
   886.4070 Powered corneal burr.
21:8.0.1.1.30.5.1.2SECTION 886.4100
   886.4100 Radiofrequency electrosurgical cautery apparatus.
21:8.0.1.1.30.5.1.3SECTION 886.4115
   886.4115 Thermal cautery unit.
21:8.0.1.1.30.5.1.4SECTION 886.4150
   886.4150 Vitreous aspiration and cutting instrument.
21:8.0.1.1.30.5.1.5SECTION 886.4155
   886.4155 Scleral plug.
21:8.0.1.1.30.5.1.6SECTION 886.4170
   886.4170 Cryophthalmic unit.
21:8.0.1.1.30.5.1.7SECTION 886.4230
   886.4230 Ophthalmic knife test drum.
21:8.0.1.1.30.5.1.8SECTION 886.4250
   886.4250 Ophthalmic electrolysis unit.
21:8.0.1.1.30.5.1.9SECTION 886.4270
   886.4270 Intraocular gas.
21:8.0.1.1.30.5.1.10SECTION 886.4275
   886.4275 Intraocular fluid.
21:8.0.1.1.30.5.1.11SECTION 886.4280
   886.4280 Intraocular pressure measuring device.
21:8.0.1.1.30.5.1.12SECTION 886.4300
   886.4300 Intraocular lens guide.
21:8.0.1.1.30.5.1.13SECTION 886.4335
   886.4335 Operating headlamp.
21:8.0.1.1.30.5.1.14SECTION 886.4350
   886.4350 Manual ophthalmic surgical instrument.
21:8.0.1.1.30.5.1.15SECTION 886.4355
   886.4355 Corneal inlay inserter handle.
21:8.0.1.1.30.5.1.16SECTION 886.4360
   886.4360 Ocular surgery irrigation device.
21:8.0.1.1.30.5.1.17SECTION 886.4370
   886.4370 Keratome.
21:8.0.1.1.30.5.1.18SECTION 886.4390
   886.4390 Ophthalmic laser.
21:8.0.1.1.30.5.1.19SECTION 886.4392
   886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
21:8.0.1.1.30.5.1.20SECTION 886.4400
   886.4400 Electronic metal locator.
21:8.0.1.1.30.5.1.21SECTION 886.4440
   886.4440 AC-powered magnet.
21:8.0.1.1.30.5.1.22SECTION 886.4445
   886.4445 Permanent magnet.
21:8.0.1.1.30.5.1.23SECTION 886.4570
   886.4570 Ophthalmic surgical marker.
21:8.0.1.1.30.5.1.24SECTION 886.4610
   886.4610 Ocular pressure applicator.
21:8.0.1.1.30.5.1.25SECTION 886.4670
   886.4670 Phacofragmentation system.
21:8.0.1.1.30.5.1.26SECTION 886.4690
   886.4690 Ophthalmic photocoagulator.
21:8.0.1.1.30.5.1.27SECTION 886.4750
   886.4750 Ophthalmic eye shield.
21:8.0.1.1.30.5.1.28SECTION 886.4770
   886.4770 Ophthalmic operating spectacles (loupes).
21:8.0.1.1.30.5.1.29SECTION 886.4790
   886.4790 Ophthalmic sponge.
21:8.0.1.1.30.5.1.30SECTION 886.4855
   886.4855 Ophthalmic instrument table.
21:8.0.1.1.30.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.30.6.1.1SECTION 886.5100
   886.5100 Ophthalmic beta radiation source.
21:8.0.1.1.30.6.1.2SECTION 886.5120
   886.5120 Low-power binocular loupe.
21:8.0.1.1.30.6.1.3SECTION 886.5200
   886.5200 Eyelid thermal pulsation system.
21:8.0.1.1.30.6.1.4SECTION 886.5300
   886.5300 Tear electrostimulation device.
21:8.0.1.1.30.6.1.5SECTION 886.5310
   886.5310 Intranasal electrostimulation device for dry eye symptoms.
21:8.0.1.1.30.6.1.6SECTION 886.5420
   886.5420 Contact lens inserter/remover.
21:8.0.1.1.30.6.1.7SECTION 886.5540
   886.5540 Low-vision magnifier.
21:8.0.1.1.30.6.1.8SECTION 886.5600
   886.5600 Ptosis crutch.
21:8.0.1.1.30.6.1.9SECTION 886.5700
   886.5700 Eyelid weight.
21:8.0.1.1.30.6.1.10SECTION 886.5800
   886.5800 Ophthalmic bar reader.
21:8.0.1.1.30.6.1.11SECTION 886.5810
   886.5810 Ophthalmic prism reader.
21:8.0.1.1.30.6.1.12SECTION 886.5820
   886.5820 Closed-circuit television reading system.
21:8.0.1.1.30.6.1.13SECTION 886.5838
   886.5838 Nasolacrimal compression device.
21:8.0.1.1.30.6.1.14SECTION 886.5840
   886.5840 Magnifying spectacles.
21:8.0.1.1.30.6.1.15SECTION 886.5842
   886.5842 Spectacle frame.
21:8.0.1.1.30.6.1.16SECTION 886.5844
   886.5844 Prescription spectacle lens.
21:8.0.1.1.30.6.1.17SECTION 886.5850
   886.5850 Sunglasses (nonprescription).
21:8.0.1.1.30.6.1.18SECTION 886.5870
   886.5870 Low-vision telescope.
21:8.0.1.1.30.6.1.19SECTION 886.5900
   886.5900 Electronic vision aid.
21:8.0.1.1.30.6.1.20SECTION 886.5905
   886.5905 Oral electronic vision aid.
21:8.0.1.1.30.6.1.21SECTION 886.5910
   886.5910 Image intensification vision aid.
21:8.0.1.1.30.6.1.22SECTION 886.5915
   886.5915 Optical vision aid.
21:8.0.1.1.30.6.1.23SECTION 886.5916
   886.5916 Rigid gas permeable contact lens.
21:8.0.1.1.30.6.1.24SECTION 886.5918
   886.5918 Rigid gas permeable contact lens care products.
21:8.0.1.1.30.6.1.25SECTION 886.5925
   886.5925 Soft (hydrophilic) contact lens.
21:8.0.1.1.30.6.1.26SECTION 886.5928
   886.5928 Soft (hydrophilic) contact lens care products.
21:8.0.1.1.30.6.1.27SECTION 886.5933
   886.5933 [Reserved]