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 03, 1989
EYE PATCH
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
9d
Cleared
Nov 03, 1989
STRAPPED EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
9d
Cleared
Nov 02, 1989
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
LZU
Plug, Punctum
63d
Cleared
Nov 02, 1989
PUPIL PATHWAY ANALYZER (PPA)
HLG
Pupillometer, Ac-powered
45d
Cleared
Nov 02, 1989
ALCON SURGICAL SPONGE
HOZ
Sponge, Ophthalmic
20d
Cleared
Nov 02, 1989
MICROSPEARS
HOZ
Sponge, Ophthalmic
14d
Cleared
Oct 31, 1989
DIATHRON(R) DIATHERMY UNIT
HJM
Transilluminator, Ac-powered
104d
Cleared
Oct 31, 1989
COBO TEMPORARY KERATOPROSTHESIS
MLP
Keratoprosthesis, Temporary Implant, Surgical Use
84d
Cleared
Oct 31, 1989
MICROLASE BY LASER TRABECULOPLASTY
HQF
Laser, Ophthalmic
74d
Cleared
Oct 31, 1989
LID LOC
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
64d
Cleared
Oct 31, 1989
CANON AUTO REF-KERATOMETER RK-2
HLQ
Keratoscope, Ac-powered
50d
Cleared
Oct 31, 1989
BIO-RAD MODULAR AIR COMPRESSOR
HKX
Tonometer, Ac-powered
47d
Cleared
Oct 17, 1989
MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
HQC
Unit, Phacofragmentation
90d
Cleared
Oct 17, 1989
PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
HQC
Unit, Phacofragmentation
90d
Cleared
Oct 16, 1989
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
66d
Cleared
Oct 04, 1989
WOLDOFF PRISMATIC BICONCAVE LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
79d
Cleared
Oct 04, 1989
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
HKI
Camera, Ophthalmic, Ac-powered
23d
Cleared
Sep 21, 1989
VISTA STREAK RETINOSCOPE (AC-POWERED)
HKL
Retinoscope, Ac-powered
149d
Cleared
Sep 21, 1989
LASERMED* GOGGLES AND SPECTACLES
HQF
Laser, Ophthalmic
52d
Cleared
Sep 21, 1989
MULTIPLE MENTAL SPECTACLE FRAMES
HQZ
Frame, Spectacle
27d
Cleared
Sep 21, 1989
FLEX EYEWEAR FRAMES
HQZ
Frame, Spectacle
23d
Cleared
Sep 14, 1989
UNIVERSAL EYESHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
51d
Cleared
Sep 14, 1989
SAFE-EDGE EYESHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
52d
Cleared
Sep 12, 1989
RELIANCE(R) 6200 EXAMINATION CHAIR
HME
Chair, Ophthalmic, Ac-powered
98d
Cleared
Sep 11, 1989
VKG 2000 VIDEO KERATOMETER
HJA
Photokeratoscope
101d
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