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