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
Sep 02, 1992
THE NISSEL ARTIFICIAL EYE
HQH
Eye, Artificial, Non-custom
65d
Cleared
Aug 31, 1992
MODIFIED SITE MACROBORE PHACO NEEDLE
HQC
Unit, Phacofragmentation
90d
Cleared
Aug 31, 1992
OPTHALMIC FRAMES
HQZ
Frame, Spectacle
89d
Cleared
Aug 26, 1992
RUBBER FRAME SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
91d
Cleared
Aug 25, 1992
THE CLEANER ACCESSORY
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
126d
Cleared
Aug 18, 1992
POLLY'S VITREOUS SCISSORS J-225-S
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
91d
Cleared
Aug 05, 1992
SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
302d
Cleared
Aug 05, 1992
OPHTHALMIC SPONGES
HOZ
Sponge, Ophthalmic
191d
Cleared
Aug 05, 1992
CYLINDER OF GAS, CAN OF GAS (CC12F2)
HKX
Tonometer, Ac-powered
121d
Cleared
Jul 30, 1992
WOODLYN CLASSIC LENSMETER
HLM
Instrument, Measuring, Lens, Ac-powered
156d
Cleared
Jul 28, 1992
SPECTACLE FRAMES
HQZ
Frame, Spectacle
90d
Cleared
Jul 27, 1992
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
154d
Cleared
Jul 27, 1992
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
KYG
Device, Irrigation, Ocular Surgery
35d
Cleared
Jul 27, 1992
OPTICAL FRAMES
HQZ
Frame, Spectacle
32d
Cleared
Jul 21, 1992
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
77d
Cleared
Jul 17, 1992
STERILE/SINGLE USE SYMBLEPHARON RING
HQN
Conformer, Ophthalmic
126d
Cleared
Jul 16, 1992
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
94d
Cleared
Jul 15, 1992
TOMEY PE-300 PORTABLE ERG
HLT
Preamplifier, Ac-powered, Ophthalmic
91d
Cleared
Jul 13, 1992
INDUSTRIAL STRENGTH EYEWEAR
HQY
Sunglasses (non-prescription Including Photosensitive)
146d
Cleared
Jul 13, 1992
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
HQG
Lens, Spectacle, Non-custom (prescription)
143d
Cleared
Jul 13, 1992
DIGI SPORTLENS SYSTEM
HQY
Sunglasses (non-prescription Including Photosensitive)
110d
Cleared
Jul 09, 1992
ORIEL
HLJ
Ophthalmoscope, Battery-powered
169d
Cleared
Jul 09, 1992
ZIESS ENDOPROBE
HQB
Photocoagulator And Accessories
31d
Cleared
Jul 02, 1992
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
97d
Cleared
Jul 02, 1992
LEWICKY O.R.S. TUBING
KYG
Device, Irrigation, Ocular Surgery
55d
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