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
Mar 05, 1984
DOWING OPHTHALMIC CHAIR-NON/AC POWER
HMD
Chair, Ophthalmic, Manual
152d
Cleared
Mar 05, 1984
DOWING OPHTHALMIC CHAIR AC-POWERED
HME
Chair, Ophthalmic, Ac-powered
152d
Cleared
Mar 05, 1984
PHAKO SYSTEMS VIA 2000
HQC
Unit, Phacofragmentation
140d
Cleared
Mar 05, 1984
DISPOS. I/A & IRRIGATION HANDPIECES
HQC
Unit, Phacofragmentation
129d
Cleared
Mar 05, 1984
JAKOBI SURG. INSTRUMENTS #6 50
HKY
Tonometer, Manual
105d
Cleared
Mar 02, 1984
TEXAS BIO SCAN
HKI
Camera, Ophthalmic, Ac-powered
136d
Cleared
Feb 21, 1984
OMYL -ARDE- SPECTACLE FRAME
HQZ
Frame, Spectacle
144d
Cleared
Feb 21, 1984
DISPOSABLE I/A HANDPIECE
HQC
Unit, Phacofragmentation
116d
Cleared
Feb 10, 1984
OCUMAP 100 AUTOPERIMETER
HPT
Perimeter, Automatic, Ac-powered
193d
Cleared
Feb 08, 1984
CROUCH CORNEAL PROTECTOR
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
141d
Cleared
Feb 04, 1984
OCULASE 514 OPHTHALMIC ARGON LASER
HQF
Laser, Ophthalmic
116d
Cleared
Feb 04, 1984
RELIANCE OPHTHALMIC SLIT LAMP R-083
HQF
Laser, Ophthalmic
71d
Cleared
Jan 30, 1984
MODEL 150K LASER COAGULATOR
HQF
Laser, Ophthalmic
221d
Cleared
Jan 30, 1984
OPHTHALMIC ARGON LASER #700A
HQF
Laser, Ophthalmic
199d
Cleared
Jan 30, 1984
ARGON LASER SYS-MODEL 5000
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
172d
Cleared
Jan 30, 1984
LASER PHOTOCOAGULATOR 1520-A & K
HQF
Laser, Ophthalmic
111d
Cleared
Jan 27, 1984
SUN BED BY VERRE ET QUARTZ UVA-FRANCE
FTZ
Locator, Magnetic
156d
Cleared
Jan 10, 1984
GELENDER VACUUM FIXATION RING SYS
HNH
Ring, Ophthalmic (flieringa)
134d
Cleared
Jan 10, 1984
STERILE OIL AND GUIDEWIRE
HNL
Probe, Lachrymal
84d
Cleared
Jan 06, 1984
IRRIGATION ASPIRATION KIT
HQC
Unit, Phacofragmentation
98d
Cleared
Jan 04, 1984
M.S.D. ASPIRATOR
HQC
Unit, Phacofragmentation
159d
Cleared
Jan 04, 1984
OSCAR COLOUR VISION TESTER
HIT
Tester, Color Vision
135d
Cleared
Jan 04, 1984
STORZ EXTRA
HQC
Unit, Phacofragmentation
118d
Cleared
Jan 04, 1984
DISPOSABLE OCUTOME PROBE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
99d
Cleared
Jan 04, 1984
CLERZ LUBRICATING/REWETTING SOLUTION
HKX
Tonometer, Ac-powered
89d
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