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 23, 2014
ACCUTIP COVER
HKY
Tonometer, Manual
252d
Cleared
Apr 23, 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
HLI
Ophthalmoscope, Ac-powered
133d
Cleared
Apr 11, 2014
DAYTONA ICG (P200TICG)
MYC
Ophthalmoscope, Laser, Scanning
101d
Cleared
Mar 27, 2014
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
MSS
Folders And Injectors, Intraocular Lens (iol)
269d
Cleared
Mar 26, 2014
AMICO DH-W35 OPHTHALMOSCOPE SERIES
HLI
Ophthalmoscope, Ac-powered
272d
Cleared
Mar 21, 2014
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
102d
Cleared
Mar 19, 2014
CIRRUS PHOTO
OBO
Tomography, Optical Coherence
152d
Cleared
Mar 19, 2014
IVUE 500
HLI
Ophthalmoscope, Ac-powered
89d
Cleared
Mar 12, 2014
STELLARIS PC VISION ENHANCEMENT SYSTEM
HQC
Unit, Phacofragmentation
119d
Cleared
Mar 11, 2014
KOWA SL-17
HJO
Biomicroscope, Slit-lamp, Ac-powered
92d
Cleared
Mar 07, 2014
HEINE MINI 3000(R) OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
253d
Cleared
Mar 05, 2014
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
LPL
Lenses, Soft Contact, Daily Wear
187d
Cleared
Mar 05, 2014
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
Mar 04, 2014
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
LPL
Lenses, Soft Contact, Daily Wear
112d
Cleared
Feb 27, 2014
COMPACT INTUITIV
HQC
Unit, Phacofragmentation
150d
Cleared
Feb 21, 2014
POLAROID CONTACTSPOD
LRX
Case, Contact Lens
249d
Cleared
Feb 21, 2014
T-TYPE D-KAT, R-TYPE D-KAT
HKY
Tonometer, Manual
123d
Cleared
Feb 19, 2014
RS-3000 ADVANCE
OBO
Tomography, Optical Coherence
209d
Cleared
Feb 14, 2014
VICTUS FEMTOSECOND LASER PLATFORM
OOE
Ophthalmic Femtosecond Laser
185d
Cleared
Feb 14, 2014
STELLARIS VISION ENHANCEMENT SYSTEM
HQC
Unit, Phacofragmentation
116d
Cleared
Feb 12, 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
LRX
Case, Contact Lens
314d
Cleared
Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
HJO
Biomicroscope, Slit-lamp, Ac-powered
92d
Cleared
Jan 29, 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
104d
Cleared
Jan 09, 2014
BAUSCH & LOMB INJECTOR SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
196d
Cleared
Jan 03, 2014
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
78d
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