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
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2883 Ophthalmic devices
Cleared
Jul 15, 2014
VICTUS FEMTOSECOND LASER PLATFORM
OOE
Ophthalmic Femtosecond Laser
127d
Cleared
Jul 11, 2014
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
HJO
Biomicroscope, Slit-lamp, Ac-powered
137d
Cleared
Jul 09, 2014
FLENTS PLASTIC EYE WASH CUP
LXQ
Cup, Eye
141d
Cleared
Jul 03, 2014
COBRA FUNDUS CAMERA
HKI
Camera, Ophthalmic, Ac-powered
282d
Cleared
Jun 25, 2014
OPTIMUS FUSION: SLT, YAG AND YAG/SLT
HQF
Laser, Ophthalmic
135d
Cleared
Jun 20, 2014
DISCOVERY SYSTEM
HJO
Biomicroscope, Slit-lamp, Ac-powered
266d
Cleared
Jun 20, 2014
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
LZU
Plug, Punctum
91d
Cleared
Jun 17, 2014
KEELER KAPTURE SOFTWARE
HKI
Camera, Ophthalmic, Ac-powered
113d
Cleared
Jun 11, 2014
OPTICAL BIOMETER AL-SCAN
HJO
Biomicroscope, Slit-lamp, Ac-powered
254d
Cleared
Jun 11, 2014
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
217d
Cleared
Jun 05, 2014
ALADDIN
HJO
Biomicroscope, Slit-lamp, Ac-powered
371d
Cleared
Jun 03, 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
LZU
Plug, Punctum
148d
Cleared
May 28, 2014
RAYSERT PLUS INJECTOR
MSS
Folders And Injectors, Intraocular Lens (iol)
30d
Cleared
May 09, 2014
YZ3 PORTABLE SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
332d
Cleared
Apr 29, 2014
FAMILY OF DISPOSABLE LENSES
HKS
Prism, Gonioscopic
74d
Cleared
Apr 28, 2014
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
300d
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
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