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
Nov 22, 1994
KERATRON CORNEAL TOPOGRAPHER
HLQ
Keratoscope, Ac-powered
63d
Cleared
Nov 22, 1994
TOMEY EM-1000 SPECULAR MICROSCOPE
HJO
Biomicroscope, Slit-lamp, Ac-powered
48d
Cleared
Nov 22, 1994
AXIOM, SUNFAST
HQY
Sunglasses (non-prescription Including Photosensitive)
47d
Cleared
Nov 22, 1994
NON-PRESCRIPTION SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
40d
Cleared
Nov 22, 1994
BRIGHTEN
HQY
Sunglasses (non-prescription Including Photosensitive)
40d
Cleared
Nov 22, 1994
ARISTAR EYEWEAR, ESPRIT EYEWEAR
HQY
Sunglasses (non-prescription Including Photosensitive)
34d
Cleared
Nov 22, 1994
ARISTAR EYEWEAR, ESPRIT EYEWEAR
HQZ
Frame, Spectacle
34d
Cleared
Nov 22, 1994
RED DRAGON CORPORATION
HQY
Sunglasses (non-prescription Including Photosensitive)
25d
Cleared
Nov 22, 1994
SPECTACLE FRAME
HQZ
Frame, Spectacle
21d
Cleared
Nov 22, 1994
SPECTACLE FRAMES OR EYEGLASS FRAMES
HQZ
Frame, Spectacle
21d
Cleared
Nov 22, 1994
MAKROLON 2405 GOGGLES (LIGHT AND DARK)
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
20d
Cleared
Nov 22, 1994
FRAME, SPECTACLE
HQZ
Frame, Spectacle
19d
Cleared
Nov 17, 1994
LENSCHEK
HLM
Instrument, Measuring, Lens, Ac-powered
92d
Cleared
Nov 15, 1994
OPTICAL FRAMES AND SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
61d
Cleared
Nov 15, 1994
SUNGLASSES AND SPECTACLE FRAMES
HQY
Sunglasses (non-prescription Including Photosensitive)
55d
Cleared
Nov 14, 1994
RETINA FLOWMETER
HLI
Ophthalmoscope, Ac-powered
91d
Cleared
Nov 14, 1994
RETINA TOMOGRAPH AND FLOWMETER
HLI
Ophthalmoscope, Ac-powered
91d
Cleared
Nov 14, 1994
RETINA ANGIOGRAPH
HLI
Ophthalmoscope, Ac-powered
74d
Cleared
Nov 14, 1994
ROYAL PLASTIC SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
69d
Cleared
Nov 14, 1994
NIL
HQZ
Frame, Spectacle
54d
Cleared
Nov 10, 1994
HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
HJM
Transilluminator, Ac-powered
618d
Cleared
Nov 10, 1994
KODI OPTICAL CO., LTD. SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
58d
Cleared
Nov 10, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
28d
Cleared
Nov 08, 1994
MANDELKORN SUTURE LYSIS LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
452d
Cleared
Oct 31, 1994
RITCH NYLON SUTURE LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
482d
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