Title 21
PART 886
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.
21:8.0.1.1.30.1 | SUBPART A | Subpart A - General Provisions | |
21:8.0.1.1.30.1.1.1 | SECTION 886.1 | 886.1 Scope. | |
21:8.0.1.1.30.1.1.2 | SECTION 886.3 | 886.3 Effective dates of requirement for premarket approval. | |
21:8.0.1.1.30.1.1.3 | SECTION 886.9 | 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). | |
21:8.0.1.1.30.2 | SUBPART B | Subpart B - Diagnostic Devices | |
21:8.0.1.1.30.2.1.1 | SECTION 886.1040 | 886.1040 Ocular esthesiometer. | |
21:8.0.1.1.30.2.1.2 | SECTION 886.1050 | 886.1050 Adaptometer (biophotometer). | |
21:8.0.1.1.30.2.1.3 | SECTION 886.1070 | 886.1070 Anomaloscope. | |
21:8.0.1.1.30.2.1.4 | SECTION 886.1090 | 886.1090 Haidinger brush. | |
21:8.0.1.1.30.2.1.5 | SECTION 886.1120 | 886.1120 Ophthalmic camera. | |
21:8.0.1.1.30.2.1.6 | SECTION 886.1140 | 886.1140 Ophthalmic chair. | |
21:8.0.1.1.30.2.1.7 | SECTION 886.1150 | 886.1150 Visual acuity chart. | |
21:8.0.1.1.30.2.1.8 | SECTION 886.1160 | 886.1160 Color vision plate illuminator. | |
21:8.0.1.1.30.2.1.9 | SECTION 886.1170 | 886.1170 Color vision tester. | |
21:8.0.1.1.30.2.1.10 | SECTION 886.1190 | 886.1190 Distometer. | |
21:8.0.1.1.30.2.1.11 | SECTION 886.1200 | 886.1200 Optokinetic drum. | |
21:8.0.1.1.30.2.1.12 | SECTION 886.1220 | 886.1220 Corneal electrode. | |
21:8.0.1.1.30.2.1.13 | SECTION 886.1250 | 886.1250 Euthyscope. | |
21:8.0.1.1.30.2.1.14 | SECTION 886.1270 | 886.1270 Exophthalmometer. | |
21:8.0.1.1.30.2.1.15 | SECTION 886.1290 | 886.1290 Fixation device. | |
21:8.0.1.1.30.2.1.16 | SECTION 886.1300 | 886.1300 Afterimage flasher. | |
21:8.0.1.1.30.2.1.17 | SECTION 886.1320 | 886.1320 Fornixscope. | |
21:8.0.1.1.30.2.1.18 | SECTION 886.1330 | 886.1330 Amsler grid. | |
21:8.0.1.1.30.2.1.19 | SECTION 886.1340 | 886.1340 Haploscope. | |
21:8.0.1.1.30.2.1.20 | SECTION 886.1342 | 886.1342 Strabismus detection device. | |
21:8.0.1.1.30.2.1.21 | SECTION 886.1350 | 886.1350 Keratoscope. | |
21:8.0.1.1.30.2.1.22 | SECTION 886.1360 | 886.1360 Visual field laser instrument. | |
21:8.0.1.1.30.2.1.23 | SECTION 886.1375 | 886.1375 Bagolini lens. | |
21:8.0.1.1.30.2.1.24 | SECTION 886.1380 | 886.1380 Diagnostic condensing lens. | |
21:8.0.1.1.30.2.1.25 | SECTION 886.1385 | 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens. | |
21:8.0.1.1.30.2.1.26 | SECTION 886.1390 | 886.1390 Flexible diagnostic Fresnel lens. | |
21:8.0.1.1.30.2.1.27 | SECTION 886.1395 | 886.1395 Diagnostic Hruby fundus lens. | |
21:8.0.1.1.30.2.1.28 | SECTION 886.1400 | 886.1400 Maddox lens. | |
21:8.0.1.1.30.2.1.29 | SECTION 886.1405 | 886.1405 Ophthalmic trial lens set. | |
21:8.0.1.1.30.2.1.30 | SECTION 886.1410 | 886.1410 Ophthalmic trial lens clip. | |
21:8.0.1.1.30.2.1.31 | SECTION 886.1415 | 886.1415 Ophthalmic trial lens frame. | |
21:8.0.1.1.30.2.1.32 | SECTION 886.1420 | 886.1420 Ophthalmic lens gauge. | |
21:8.0.1.1.30.2.1.33 | SECTION 886.1425 | 886.1425 Lens measuring instrument. | |
21:8.0.1.1.30.2.1.34 | SECTION 886.1430 | 886.1430 Ophthalmic contact lens radius measuring device. | |
21:8.0.1.1.30.2.1.35 | SECTION 886.1435 | 886.1435 Maxwell spot. | |
21:8.0.1.1.30.2.1.36 | SECTION 886.1450 | 886.1450 Corneal radius measuring device. | |
21:8.0.1.1.30.2.1.37 | SECTION 886.1460 | 886.1460 Stereopsis measuring instrument. | |
21:8.0.1.1.30.2.1.38 | SECTION 886.1500 | 886.1500 Headband mirror. | |
21:8.0.1.1.30.2.1.39 | SECTION 886.1510 | 886.1510 Eye movement monitor. | |
21:8.0.1.1.30.2.1.40 | SECTION 886.1570 | 886.1570 Ophthalmoscope. | |
21:8.0.1.1.30.2.1.41 | SECTION 886.1605 | 886.1605 Perimeter. | |
21:8.0.1.1.30.2.1.42 | SECTION 886.1630 | 886.1630 AC-powered photostimulator. | |
21:8.0.1.1.30.2.1.43 | SECTION 886.1640 | 886.1640 Ophthalmic preamplifier. | |
21:8.0.1.1.30.2.1.44 | SECTION 886.1650 | 886.1650 Ophthalmic bar prism. | |
21:8.0.1.1.30.2.1.45 | SECTION 886.1655 | 886.1655 Ophthalmic Fresnel prism. | |
21:8.0.1.1.30.2.1.46 | SECTION 886.1660 | 886.1660 Gonioscopic prism. | |
21:8.0.1.1.30.2.1.47 | SECTION 886.1665 | 886.1665 Ophthalmic rotary prism. | |
21:8.0.1.1.30.2.1.48 | SECTION 886.1670 | 886.1670 Ophthalmic isotope uptake probe. | |
21:8.0.1.1.30.2.1.49 | SECTION 886.1680 | 886.1680 Ophthalmic projector. | |
21:8.0.1.1.30.2.1.50 | SECTION 886.1690 | 886.1690 Pupillograph. | |
21:8.0.1.1.30.2.1.51 | SECTION 886.1700 | 886.1700 Pupillometer. | |
21:8.0.1.1.30.2.1.52 | SECTION 886.1750 | 886.1750 Skiascopic rack. | |
21:8.0.1.1.30.2.1.53 | SECTION 886.1760 | 886.1760 Ophthalmic refractometer. | |
21:8.0.1.1.30.2.1.54 | SECTION 886.1770 | 886.1770 Manual refractor. | |
21:8.0.1.1.30.2.1.55 | SECTION 886.1780 | 886.1780 Retinoscope. | |
21:8.0.1.1.30.2.1.56 | SECTION 886.1790 | 886.1790 Nearpoint ruler. | |
21:8.0.1.1.30.2.1.57 | SECTION 886.1800 | 886.1800 Schirmer strip. | |
21:8.0.1.1.30.2.1.58 | SECTION 886.1810 | 886.1810 Tangent screen (campimeter). | |
21:8.0.1.1.30.2.1.59 | SECTION 886.1840 | 886.1840 Simulatan (including crossed cylinder). | |
21:8.0.1.1.30.2.1.60 | SECTION 886.1850 | 886.1850 AC-powered slitlamp biomicroscope. | |
21:8.0.1.1.30.2.1.61 | SECTION 886.1860 | 886.1860 Ophthalmic instrument stand. | |
21:8.0.1.1.30.2.1.62 | SECTION 886.1870 | 886.1870 Stereoscope. | |
21:8.0.1.1.30.2.1.63 | SECTION 886.1880 | 886.1880 Fusion and stereoscopic target. | |
21:8.0.1.1.30.2.1.64 | SECTION 886.1905 | 886.1905 Nystagmus tape. | |
21:8.0.1.1.30.2.1.65 | SECTION 886.1910 | 886.1910 Spectacle dissociation test system. | |
21:8.0.1.1.30.2.1.66 | SECTION 886.1925 | 886.1925 Diurnal pattern recorder system. | |
21:8.0.1.1.30.2.1.67 | SECTION 886.1930 | 886.1930 Tonometer and accessories. | |
21:8.0.1.1.30.2.1.68 | SECTION 886.1940 | 886.1940 Tonometer sterilizer. | |
21:8.0.1.1.30.2.1.69 | SECTION 886.1945 | 886.1945 Transilluminator. | |
21:8.0.1.1.30.3 | SUBPART C | Subpart C [Reserved] | |
21:8.0.1.1.30.4 | SUBPART D | Subpart D - Prosthetic Devices | |
21:8.0.1.1.30.4.1.1 | SECTION 886.3100 | 886.3100 Ophthalmic tantalum clip. | |
21:8.0.1.1.30.4.1.2 | SECTION 886.3130 | 886.3130 Ophthalmic conformer. | |
21:8.0.1.1.30.4.1.3 | SECTION 886.3200 | 886.3200 Artificial eye. | |
21:8.0.1.1.30.4.1.4 | SECTION 886.3300 | 886.3300 Absorbable implant (scleral buckling method). | |
21:8.0.1.1.30.4.1.5 | SECTION 886.3320 | 886.3320 Eye sphere implant. | |
21:8.0.1.1.30.4.1.6 | SECTION 886.3340 | 886.3340 Extraocular orbital implant. | |
21:8.0.1.1.30.4.1.7 | SECTION 886.3400 | 886.3400 Keratoprosthesis. | |
21:8.0.1.1.30.4.1.8 | SECTION 886.3600 | 886.3600 Intraocular lens. | |
21:8.0.1.1.30.4.1.9 | SECTION 886.3800 | 886.3800 Scleral shell. | |
21:8.0.1.1.30.4.1.10 | SECTION 886.3920 | 886.3920 Aqueous shunt. | |
21:8.0.1.1.30.5 | SUBPART E | Subpart E - Surgical Devices | |
21:8.0.1.1.30.5.1.1 | SECTION 886.4070 | 886.4070 Powered corneal burr. | |
21:8.0.1.1.30.5.1.2 | SECTION 886.4100 | 886.4100 Radiofrequency electrosurgical cautery apparatus. | |
21:8.0.1.1.30.5.1.3 | SECTION 886.4115 | 886.4115 Thermal cautery unit. | |
21:8.0.1.1.30.5.1.4 | SECTION 886.4150 | 886.4150 Vitreous aspiration and cutting instrument. | |
21:8.0.1.1.30.5.1.5 | SECTION 886.4155 | 886.4155 Scleral plug. | |
21:8.0.1.1.30.5.1.6 | SECTION 886.4170 | 886.4170 Cryophthalmic unit. | |
21:8.0.1.1.30.5.1.7 | SECTION 886.4230 | 886.4230 Ophthalmic knife test drum. | |
21:8.0.1.1.30.5.1.8 | SECTION 886.4250 | 886.4250 Ophthalmic electrolysis unit. | |
21:8.0.1.1.30.5.1.9 | SECTION 886.4270 | 886.4270 Intraocular gas. | |
21:8.0.1.1.30.5.1.10 | SECTION 886.4275 | 886.4275 Intraocular fluid. | |
21:8.0.1.1.30.5.1.11 | SECTION 886.4280 | 886.4280 Intraocular pressure measuring device. | |
21:8.0.1.1.30.5.1.12 | SECTION 886.4300 | 886.4300 Intraocular lens guide. | |
21:8.0.1.1.30.5.1.13 | SECTION 886.4335 | 886.4335 Operating headlamp. | |
21:8.0.1.1.30.5.1.14 | SECTION 886.4350 | 886.4350 Manual ophthalmic surgical instrument. | |
21:8.0.1.1.30.5.1.15 | SECTION 886.4355 | 886.4355 Corneal inlay inserter handle. | |
21:8.0.1.1.30.5.1.16 | SECTION 886.4360 | 886.4360 Ocular surgery irrigation device. | |
21:8.0.1.1.30.5.1.17 | SECTION 886.4370 | 886.4370 Keratome. | |
21:8.0.1.1.30.5.1.18 | SECTION 886.4390 | 886.4390 Ophthalmic laser. | |
21:8.0.1.1.30.5.1.19 | SECTION 886.4392 | 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. | |
21:8.0.1.1.30.5.1.20 | SECTION 886.4400 | 886.4400 Electronic metal locator. | |
21:8.0.1.1.30.5.1.21 | SECTION 886.4440 | 886.4440 AC-powered magnet. | |
21:8.0.1.1.30.5.1.22 | SECTION 886.4445 | 886.4445 Permanent magnet. | |
21:8.0.1.1.30.5.1.23 | SECTION 886.4570 | 886.4570 Ophthalmic surgical marker. | |
21:8.0.1.1.30.5.1.24 | SECTION 886.4610 | 886.4610 Ocular pressure applicator. | |
21:8.0.1.1.30.5.1.25 | SECTION 886.4670 | 886.4670 Phacofragmentation system. | |
21:8.0.1.1.30.5.1.26 | SECTION 886.4690 | 886.4690 Ophthalmic photocoagulator. | |
21:8.0.1.1.30.5.1.27 | SECTION 886.4750 | 886.4750 Ophthalmic eye shield. | |
21:8.0.1.1.30.5.1.28 | SECTION 886.4770 | 886.4770 Ophthalmic operating spectacles (loupes). | |
21:8.0.1.1.30.5.1.29 | SECTION 886.4790 | 886.4790 Ophthalmic sponge. | |
21:8.0.1.1.30.5.1.30 | SECTION 886.4855 | 886.4855 Ophthalmic instrument table. | |
21:8.0.1.1.30.6 | SUBPART F | Subpart F - Therapeutic Devices | |
21:8.0.1.1.30.6.1.1 | SECTION 886.5100 | 886.5100 Ophthalmic beta radiation source. | |
21:8.0.1.1.30.6.1.2 | SECTION 886.5120 | 886.5120 Low-power binocular loupe. | |
21:8.0.1.1.30.6.1.3 | SECTION 886.5200 | 886.5200 Eyelid thermal pulsation system. | |
21:8.0.1.1.30.6.1.4 | SECTION 886.5300 | 886.5300 Tear electrostimulation device. | |
21:8.0.1.1.30.6.1.5 | SECTION 886.5310 | 886.5310 Intranasal electrostimulation device for dry eye symptoms. | |
21:8.0.1.1.30.6.1.6 | SECTION 886.5420 | 886.5420 Contact lens inserter/remover. | |
21:8.0.1.1.30.6.1.7 | SECTION 886.5540 | 886.5540 Low-vision magnifier. | |
21:8.0.1.1.30.6.1.8 | SECTION 886.5600 | 886.5600 Ptosis crutch. | |
21:8.0.1.1.30.6.1.9 | SECTION 886.5700 | 886.5700 Eyelid weight. | |
21:8.0.1.1.30.6.1.10 | SECTION 886.5800 | 886.5800 Ophthalmic bar reader. | |
21:8.0.1.1.30.6.1.11 | SECTION 886.5810 | 886.5810 Ophthalmic prism reader. | |
21:8.0.1.1.30.6.1.12 | SECTION 886.5820 | 886.5820 Closed-circuit television reading system. | |
21:8.0.1.1.30.6.1.13 | SECTION 886.5838 | 886.5838 Nasolacrimal compression device. | |
21:8.0.1.1.30.6.1.14 | SECTION 886.5840 | 886.5840 Magnifying spectacles. | |
21:8.0.1.1.30.6.1.15 | SECTION 886.5842 | 886.5842 Spectacle frame. | |
21:8.0.1.1.30.6.1.16 | SECTION 886.5844 | 886.5844 Prescription spectacle lens. | |
21:8.0.1.1.30.6.1.17 | SECTION 886.5850 | 886.5850 Sunglasses (nonprescription). | |
21:8.0.1.1.30.6.1.18 | SECTION 886.5870 | 886.5870 Low-vision telescope. | |
21:8.0.1.1.30.6.1.19 | SECTION 886.5900 | 886.5900 Electronic vision aid. | |
21:8.0.1.1.30.6.1.20 | SECTION 886.5905 | 886.5905 Oral electronic vision aid. | |
21:8.0.1.1.30.6.1.21 | SECTION 886.5910 | 886.5910 Image intensification vision aid. | |
21:8.0.1.1.30.6.1.22 | SECTION 886.5915 | 886.5915 Optical vision aid. | |
21:8.0.1.1.30.6.1.23 | SECTION 886.5916 | 886.5916 Rigid gas permeable contact lens. | |
21:8.0.1.1.30.6.1.24 | SECTION 886.5918 | 886.5918 Rigid gas permeable contact lens care products. | |
21:8.0.1.1.30.6.1.25 | SECTION 886.5925 | 886.5925 Soft (hydrophilic) contact lens. | |
21:8.0.1.1.30.6.1.26 | SECTION 886.5928 | 886.5928 Soft (hydrophilic) contact lens care products. | |
21:8.0.1.1.30.6.1.27 | SECTION 886.5933 | 886.5933 [Reserved] |