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
5119
Total
5101
Cleared
169d
Avg (2y)
1976
Since
5119 Ophthalmic devices
Cleared
Jan 02, 1985
COLOR VISION TESTERS
HIT
Tester, Color Vision
50d
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 13, 1984
LASERSPEC
251d
Cleared
Dec 11, 1984
MULTIPLE LENS, SPECTACLES, CUSTOM
HQG
Lens, Spectacle, Non-custom (prescription)
190d
Cleared
Dec 11, 1984
MULTIPLE-LENS, SPECTACLES, CUSTOM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
190d
Cleared
Dec 11, 1984
MULTIPLE LENS, SPECTACLES CUSTOM
HQG
Lens, Spectacle, Non-custom (prescription)
190d
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
OPHTHALMIC CHAIR
HMF
Stand, Instrument, Ac-powered, Ophthalmic
28d
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
Dec 11, 1984
SPECTABLE FRAME MAGNIFYING BRILLETTE
HOJ
Screen, Tangent, Target
12d
Cleared
Dec 11, 1984
SPECTABLE FRAME - PRODESIGN SUN CLUB
HQZ
Frame, Spectacle
12d
Cleared
Dec 05, 1984
OPHTHALMIC STAND
HMF
Stand, Instrument, Ac-powered, Ophthalmic
22d
Cleared
Dec 05, 1984
QUANTUM 412
HPT
Perimeter, Automatic, Ac-powered
12d
Cleared
Dec 03, 1984
EASY EYES TM LENS CARRYING CASE
HPX
Lens, Contact (polymethylmethacrylate)
210d
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