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
Apr 06, 1994
MTI PHOTOSCREENER
MMF
Photorefractor
176d
Cleared
Apr 06, 1994
JIN CHANG SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
127d
Cleared
Apr 06, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
126d
Cleared
Apr 06, 1994
SPECTACLE FRAMES
HQZ
Frame, Spectacle
119d
Cleared
Apr 06, 1994
SPECTACLE FRAMES AND SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
114d
Cleared
Apr 06, 1994
SPECTACLE FRAME
HQZ
Frame, Spectacle
72d
Cleared
Apr 06, 1994
TALKING RAP SHADES
HQY
Sunglasses (non-prescription Including Photosensitive)
68d
Cleared
Apr 06, 1994
SPECTACLE FRAMES
HQZ
Frame, Spectacle
58d
Cleared
Apr 06, 1994
E.M.A.
HQZ
Frame, Spectacle
51d
Cleared
Apr 06, 1994
SUNGLASSES (NON-PRESCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
43d
Cleared
Apr 01, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
161d
Cleared
Apr 01, 1994
OSHER SURGICAL GONIO/POSTERIOR POLE LENS
HKS
Prism, Gonioscopic
150d
Cleared
Apr 01, 1994
SCMD KERATOME
HNO
Keratome, Ac-powered
147d
Cleared
Apr 01, 1994
MEGABEAM ENDOCULAR PROBE
HQF
Laser, Ophthalmic
121d
Cleared
Apr 01, 1994
SLIT LAMP, H-201
HJO
Biomicroscope, Slit-lamp, Ac-powered
93d
Cleared
Mar 24, 1994
SUNGLASSES (NON-PERSCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
189d
Cleared
Mar 24, 1994
UNIVERSAL CUSHIONED METAL EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
69d
Cleared
Mar 24, 1994
UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
62d
Cleared
Mar 24, 1994
ORVIS RIVER GUIDE GLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
62d
Cleared
Mar 24, 1994
ORVIS MARQUESAS FISHING GLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
58d
Cleared
Mar 14, 1994
360 DEGREE FIXATION LIGHT
HPL
Device, Fixation, Ac-powered, Ophthalmic
223d
Cleared
Mar 14, 1994
OPHTHALMIC SURGICAL SYSTEM
HQC
Unit, Phacofragmentation
133d
Cleared
Mar 14, 1994
SPORTS RADIO SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
87d
Cleared
Mar 07, 1994
STORZ FIBEROPTIC PICK MANIPULATOR
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
208d
Cleared
Mar 01, 1994
POST-MYDS(TM)
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
377d
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