FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
889–912 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
K120057 · HLI
Bioptigen, Inc.
Ophthalmic · 123d
Cleared May 10, 2012
ILWAIT TIMER OCULOPRESSOR
K112952 · LCC
Oryx Medical Pty, Ltd.
Ophthalmic · 218d
Cleared May 08, 2012
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
K113451 · HKI
Nidek Technologies Srl
Ophthalmic · 169d
Cleared Apr 30, 2012
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
K112909 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 210d
Cleared Apr 26, 2012
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K110835 · LPL
GEO MEDICAL CO., LTD.
Ophthalmic · 398d
Cleared Apr 23, 2012
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857 · HQB
Synergetics, Inc.
Ophthalmic · 115d
Cleared Apr 18, 2012
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
K113586 · HQD
Synergeyes, Inc.
Ophthalmic · 135d
Cleared Apr 17, 2012
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
K120028 · LPL
Pegavision Corporation
Ophthalmic · 104d
Cleared Apr 11, 2012
KONAN SPECULAR MICROSCOPE XIV
K120264 · NQE
Konan Medical, Inc.
Ophthalmic · 72d
Cleared Apr 03, 2012
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · LPL
CooperVision, Inc.
Ophthalmic · 104d
Cleared Apr 03, 2012
RTVUE XR OCT
K120238 · HLI
Optovue, Inc.
Ophthalmic · 68d
Cleared Mar 30, 2012
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES...
K113168 · LPL
Ciba Vision Corporation
Ophthalmic · 155d
Cleared Mar 27, 2012
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III...
K112977 · MSS
Alcon Research, Ltd.
Ophthalmic · 173d
Cleared Mar 16, 2012
FEMTO LDV
K112154 · HQF
Sie Ag,Surgical Instument Engineering
Ophthalmic · 233d
Cleared Feb 16, 2012
KOWA VX-20
K112330 · HKI
Kowa Co. , Ltd.
Ophthalmic · 188d
Cleared Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND...
K111877 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 207d
Cleared Jan 19, 2012
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and...
K111157 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 269d
Cleared Dec 29, 2011
TRIMOTION INJECTOR
K102999 · OTZ
Kaneka Corp.
Ophthalmic · 447d
Cleared Dec 21, 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
K111446 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 211d
Cleared Dec 21, 2011
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC,...
K112302 · LPL
CooperVision, Inc.
Ophthalmic · 132d
Cleared Dec 21, 2011
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K113479 · OOE
Optimedica Corporation
Ophthalmic · 28d
Cleared Dec 19, 2011
LIPIFLOW THERMAL PULSATION SYSTEM
K112704 · ORZ
Tearscience, Inc.
Ophthalmic · 94d
Cleared Dec 08, 2011
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
K112093 · HRN
Keeler Instruments, Inc.
Ophthalmic · 139d
Cleared Dec 05, 2011
EYE CARE CURE CONTACT LENS CASE
K112832 · LRX
Eye Care and Cure
Ophthalmic · 67d