FDA 510(k) Ophthalmic Devices
FDA 510(k) Ophthalmic Devices - Regulatory Overview
FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.
Main categories:
- Contact lenses - daily, extended wear, toric and multifocal lenses
- Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
- Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
- Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
- Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2903 Ophthalmic devices
Cleared
Dec 27, 1984
SITE ULTRASONIC EMULSIFICATION MODULE OP
HQC
Unit, Phacofragmentation
27d
Cleared
Dec 24, 1984
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
HQB
Photocoagulator And Accessories
55d
Cleared
Dec 24, 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
HQB
Photocoagulator And Accessories
55d
Cleared
Dec 24, 1984
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
17d
Cleared
Dec 19, 1984
MVS XII
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
155d
Cleared
Dec 19, 1984
INFUSION ASPIRATION VITRECTOMY SYS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
112d
Cleared
Dec 19, 1984
CANON AUTO KERATOMETER K-1
HLI
Ophthalmoscope, Ac-powered
62d
Cleared
Dec 18, 1984
LANDERS-FOULKS TEMP. KERATOPROSTHESIS
MLP
Keratoprosthesis, Temporary Implant, Surgical Use
151d
Cleared
Dec 11, 1984
COOPERVISION SYSTEM VI
HQC
Unit, Phacofragmentation
139d
Cleared
Dec 11, 1984
WOODLYN CLASSIC CATARACT ACUITY TEST
HLI
Ophthalmoscope, Ac-powered
74d
Cleared
Dec 11, 1984
MEDICAL OPTICS PHACOEMULSIFICATION KIT
HQC
Unit, Phacofragmentation
48d
Cleared
Dec 11, 1984
O.M.S. GUILLOTINE CUTTER
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
28d
Cleared
Dec 11, 1984
OMS SCISSORS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
21d
Cleared
Dec 11, 1984
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
HNN
Knife, Ophthalmic
20d
Cleared
Nov 29, 1984
VISITEC MAGNIFYING SPECTACLES
HOI
Spectacle, Magnifying
44d
Cleared
Nov 27, 1984
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
HQC
Unit, Phacofragmentation
120d
Cleared
Nov 27, 1984
IOCARE IRRIGATION/ASPIRATION PACK
HQC
Unit, Phacofragmentation
99d
Cleared
Nov 27, 1984
IOCARE PHACOEMULSIFICATION PACK
HQC
Unit, Phacofragmentation
99d
Cleared
Nov 27, 1984
IOCARE ULTRASONIC TITANIUM TIPS
HQC
Unit, Phacofragmentation
99d
Cleared
Nov 27, 1984
MENDEZ U/S CYSTOTOME
HQC
Unit, Phacofragmentation
91d
Cleared
Nov 21, 1984
OPERAID SURGICAL DRAIN
HOZ
Sponge, Ophthalmic
210d
Cleared
Nov 21, 1984
OPERAID NUCLEUS
KYG
Device, Irrigation, Ocular Surgery
204d
Cleared
Nov 21, 1984
AUTOMATED INTRAOCULAR SCISSORS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
149d
Cleared
Nov 21, 1984
SITE ANTERIOR CAPSULOTOMER
HMX
Cannula, Ophthalmic
111d
Cleared
Nov 21, 1984
BINOCULAR INDIRECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
90d
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