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
961–984 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 23, 2011
SLIT LAMP SL-2G
K110489 · HJO
Topcon Medical Systems, Inc.
Ophthalmic · 90d
Cleared May 20, 2011
CLEARCUT S SAFETY KNIFE
K110166 · HNN
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared May 18, 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
K110006 · NFJ
Ophthalmic Imaging Systems
Ophthalmic · 135d
Cleared May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K110986 · HKI
Optomed OY
Ophthalmic · 38d
Cleared May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
K110528 · FSR
Integra LifeSciences Corporation
Ophthalmic · 76d
Cleared CT May 10, 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · LPN
Alcon Research, Ltd.
Ophthalmic · 222d
Cleared Apr 28, 2011
ONE DAY FLAT PACK
K102895 · LPL
Menicon Co, Ltd.
Ophthalmic · 210d
Cleared Apr 26, 2011
NOVAKONE SPHERICAL AND TORIC LENSES
K102557 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 231d
Cleared Apr 20, 2011
RETCAM 3 OPTHALMIC IMAGING SYSTEM
K102859 · HKI
Clarity Medical Systems
Ophthalmic · 202d
Cleared Apr 20, 2011
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX...
K110452 · LPL
Unilens Corp., USA
Ophthalmic · 63d
Cleared Apr 08, 2011
ULTIMATE VIT ENHAMCER (UVE)
K102222 · HQE
Medical Instrument Development...
Ophthalmic · 245d
Cleared Mar 16, 2011
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
K102727 · OOE
Lensar, Inc.
Ophthalmic · 175d
Cleared Feb 25, 2011
ADAPT, MODEL AX-03SN
K100954 · OUM
Apeliotus Vision Science, Inc.
Ophthalmic · 324d
Cleared Feb 23, 2011
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
K110228 · HQB
Nidek Incorporated
Ophthalmic · 28d
Cleared Feb 09, 2011
AAIO-7, AAIO WIRLESS
K110205 · HLI
Appasamy Associates
Ophthalmic · 15d
Cleared Feb 03, 2011
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K103561 · HQD
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Feb 01, 2011
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
K103056 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 109d
Cleared Jan 26, 2011
KOWA NONMYD WX
K101628 · HKI
Kowa Co. , Ltd.
Ophthalmic · 230d
Cleared Jan 21, 2011
ENDOSERTER
K090626 · OTZ
Ocular Systems, Inc.
Ophthalmic · 683d
Cleared Jan 21, 2011
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL,...
K102154 · HQD
The Lagado Corp.
Ophthalmic · 175d
Cleared Jan 19, 2011
STERILE SALINE SOLUTION
K102165 · LPN
Cachet Pharmaceuticals Pvt. , Ltd.
Ophthalmic · 170d
Cleared Jan 12, 2011
ISCREEN VISION SCREENER
K102651 · HKI
Iscreen Vision, Inc.
Ophthalmic · 120d
Cleared Dec 22, 2010
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
K101782 · MSS
Staar Japan
Ophthalmic · 180d
Cleared Dec 22, 2010
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
K101861 · HKI
Truevision Systems, Incorporated
Ophthalmic · 173d