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
721–744 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 26, 2014
SLIT LAMP SL-D701
K133667 · HJO
Topcon Corp.
Ophthalmic · 270d
Cleared Aug 22, 2014
CONSTELLATION VISION SYSTEM
K141065 · HQE
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE...
K133358 · HQF
Nidek Co., Ltd.
Ophthalmic · 285d
Cleared Aug 12, 2014
CATARHEX 3
K133562 · HQC
Oertli Instrumente AG
Ophthalmic · 265d
Cleared Jul 18, 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
K141280 · LPL
Seinoh Optical Co. , Ltd.
Ophthalmic · 63d
Cleared Jul 15, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K140615 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 127d
Cleared Jul 11, 2014
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP...
K140451 · HJO
Keeler Limited
Ophthalmic · 137d
Cleared Jul 09, 2014
FLENTS PLASTIC EYE WASH CUP
K140409 · LXQ
Apothecary Products, Inc.
Ophthalmic · 141d
Cleared Jul 03, 2014
COBRA FUNDUS CAMERA
K132987 · HKI
C.S.O. S.R.L.
Ophthalmic · 282d
Cleared Jun 25, 2014
OPTIMUS FUSION: SLT, YAG AND YAG/SLT
K140336 · HQF
Quantel Medical
Ophthalmic · 135d
Cleared Jun 20, 2014
DISCOVERY SYSTEM
K133062 · HJO
Innovative Visual Systems
Ophthalmic · 266d
Cleared Jun 20, 2014
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM...
K140711 · LZU
Paragon Bioteck, Inc.
Ophthalmic · 91d
Cleared Jun 17, 2014
KEELER KAPTURE SOFTWARE
K140450 · HKI
Keeler Limited
Ophthalmic · 113d
Cleared Jun 11, 2014
OPTICAL BIOMETER AL-SCAN
K133132 · HJO
Nidek Co., Ltd.
Ophthalmic · 254d
Cleared Jun 11, 2014
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT...
K133403 · LPL
Firestone Optics, Inc.
Ophthalmic · 217d
Cleared Jun 05, 2014
ALADDIN
K131567 · HJO
Visia Imaging S.R.L.
Ophthalmic · 371d
Cleared Jun 03, 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K140026 · LZU
Lacrimedics, Inc.
Ophthalmic · 148d
Cleared May 28, 2014
RAYSERT PLUS INJECTOR
K141091 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 30d
Cleared May 09, 2014
YZ3 PORTABLE SLIT LAMP
K131711 · HJO
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 332d
Cleared Apr 29, 2014
FAMILY OF DISPOSABLE LENSES
K140368 · HKS
Sensor Medical Technology, LLC
Ophthalmic · 74d
Cleared Apr 28, 2014
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
K132042 · HOY
X6d, Ltd.
Ophthalmic · 300d
Cleared Apr 23, 2014
ACCUTIP COVER
K132549 · HKY
Accutome, Inc.
Ophthalmic · 252d
Cleared Apr 23, 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · HLI
Centervue S.P.A.
Ophthalmic · 133d
Cleared Apr 11, 2014
DAYTONA ICG (P200TICG)
K134039 · MYC
Optos Plc.
Ophthalmic · 101d