Part 886 — Ophthalmic Devices
Subpart A — General Provisions
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 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.
- § 886.5350— Ultrasound cyclodestructive device.
- § 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.
- § 886.5919— Hydrophilic re-coating solution.
- § 886.5925— Soft (hydrophilic) contact lens.
- § 886.5928— Soft (hydrophilic) contact lens care products.