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
Dec 28, 1994
HORIZON 55 BI-CON
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
Dec 22, 1994
ARCTIC PREMIER SERIES
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
90d
Cleared
Dec 19, 1994
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
76d
Cleared
Dec 15, 1994
ADVANCE CORP. SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
106d
Cleared
Dec 15, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
97d
Cleared
Dec 15, 1994
GOGGLE SAFEGUARD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
76d
Cleared
Dec 15, 1994
SPECTACLE FRAME OR EYEGLASS FRAMES
HQZ
Frame, Spectacle
52d
Cleared
Dec 15, 1994
SPECTACLE FRAME
HQZ
Frame, Spectacle
42d
Cleared
Dec 15, 1994
OPTICAL FRAMES
HQZ
Frame, Spectacle
43d
Cleared
Dec 13, 1994
FRAME, SPECTACLES
HQZ
Frame, Spectacle
90d
Cleared
Dec 13, 1994
SHIELD, EYE, OPHTHALMIC
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
90d
Cleared
Dec 07, 1994
DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
HLT
Preamplifier, Ac-powered, Ophthalmic
834d
Cleared
Dec 07, 1994
TOPOGRAPHIC MODELING SYSTEM 2 TMS-2
HLQ
Keratoscope, Ac-powered
100d
Cleared
Dec 07, 1994
ACCUCON
HQD
Lens, Contact (other Material) - Daily
99d
Cleared
Dec 07, 1994
MULTIPLE
HQY
Sunglasses (non-prescription Including Photosensitive)
40d
Cleared
Dec 07, 1994
MULTIPLE
HQY
Sunglasses (non-prescription Including Photosensitive)
36d
Cleared
Dec 05, 1994
CASSETTE SYSTEM FOR STORZ
HQC
Unit, Phacofragmentation
166d
Cleared
Dec 05, 1994
COLLEGIATE COLORS
HQY
Sunglasses (non-prescription Including Photosensitive)
53d
Cleared
Nov 28, 1994
STORZ PHACO AND FRAG HANDPIECES
HQC
Unit, Phacofragmentation
350d
Cleared
Nov 28, 1994
MAG-1 SPECTACLE FRAME
HQZ
Frame, Spectacle
27d
Cleared
Nov 22, 1994
UNBREAKABLE LENS
HQY
Sunglasses (non-prescription Including Photosensitive)
243d
Cleared
Nov 22, 1994
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
HNO
Keratome, Ac-powered
237d
Cleared
Nov 22, 1994
KEELER MULTILASE 3000
HQF
Laser, Ophthalmic
202d
Cleared
Nov 22, 1994
SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR
HQY
Sunglasses (non-prescription Including Photosensitive)
81d
Cleared
Nov 22, 1994
FOCOMETER
HLJ
Ophthalmoscope, Battery-powered
71d
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