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
Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
139d
Cleared
Sep 10, 2014
CONTACT LENS CASE
LRX
Case, Contact Lens
195d
Cleared
Sep 10, 2014
EyeSuite Imaging
NFJ
System, Image Management, Ophthalmic
13d
Cleared
Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
HJO
Biomicroscope, Slit-lamp, Ac-powered
138d
Cleared
Aug 26, 2014
SLIT LAMP SL-D701
HJO
Biomicroscope, Slit-lamp, Ac-powered
270d
Cleared
Aug 22, 2014
CONSTELLATION VISION SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
120d
Cleared
Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
HQF
Laser, Ophthalmic
285d
Cleared
Aug 12, 2014
CATARHEX 3
HQC
Unit, Phacofragmentation
265d
Cleared
Jul 18, 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
63d
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
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