Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
889–912 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 28, 2012
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92...
K120996 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Jun 21, 2012
VERSAVIT
K121675 · HQE
Synergetics, Inc.
Ophthalmic · 15d
Cleared Jun 18, 2012
CIRRUS PHOTO
K112184 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 326d
Cleared Jun 15, 2012
INFINITI(R) VISION SYSTEM
K120912 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 81d
Cleared Jun 08, 2012
TBD
K120214 · OOE
Lensar, Inc.
Ophthalmic · 136d
Cleared CT Jun 05, 2012
BAUSCH + LOMB NESOFILCON A CONTACT LENS
K113703 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 172d
Cleared May 31, 2012
NCI SPATULA
K110734 · OTZ
Fischer Surgical, Inc.
Ophthalmic · 442d
Cleared May 30, 2012
PROCARE PLUS VITRECTOMY SYSTEM
K120170 · HQE
Visioncare Devices, Inc.
Ophthalmic · 132d
Cleared May 25, 2012
OPTOS ADVANCE
K113696 · NFJ
Optos Plc.
Ophthalmic · 161d
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 CT 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