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
961–984 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Dec 10, 2010
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · HKX
Keeler Instruments, Inc.
Ophthalmic · 415d
Cleared Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495 · HLJ
American Diagnostic Corp.
Ophthalmic · 374d
Cleared Nov 17, 2010
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
K093071 · HKI
Fundus Photo, LLC
Ophthalmic · 413d
Cleared Nov 12, 2010
CONSTELLATION VISION SYSTEM
K101285 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 189d
Cleared Nov 03, 2010
IOLMASTER 500
K101182 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 190d
Cleared Oct 29, 2010
DIGITAL RETINAL CAMERA
K102013 · HKI
Canon Inc. -Medical Equipment Group
Ophthalmic · 105d
Cleared Oct 28, 2010
METRO SOFT
K100244 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 274d
Cleared Oct 28, 2010
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
K100443 · LPL
X-Cel Contacts, Inc.
Ophthalmic · 253d
Cleared Oct 28, 2010
CVUE ADVANCED DEFINITIVE
K100456 · LPL
Unilens Corp., USA
Ophthalmic · 253d