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
1177–1200 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 08, 2007
EUSOL-C
K063617 · LYX
Al.Chi.Mi.A
Ophthalmic · 65d
Cleared Jan 26, 2007
CIRRUS HD-OCT, MODEL 4000
K063378 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 79d
Cleared Jan 23, 2007
CF-1
K063717 · HKI
Canon, Inc.
Ophthalmic · 40d
Cleared Dec 20, 2006
XCEL 255 SLIT LAMP
K063750 · HJO
Reichert, Inc.
Ophthalmic · 1d
Cleared Dec 19, 2006
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
K063331 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 46d
Cleared Dec 18, 2006
KOWA SL-15
K063640 · HJO
Kowa Co. , Ltd.
Ophthalmic · 11d
Cleared Dec 13, 2006
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
K062612 · MSS
Rayner Surgical, Inc.
Ophthalmic · 99d
Cleared Dec 13, 2006
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
K063343 · HLI
Bioptigen, Inc.
Ophthalmic · 37d
Cleared Dec 07, 2006
LUXVISION SLIT LAMP
K063416 · HJO
Us Ophthalmic, LLC
Ophthalmic · 24d
Cleared Nov 22, 2006
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · MVN
CooperVision, Inc.
Ophthalmic · 135d
Cleared Nov 17, 2006
RETINAL FUNCTIONAL IMAGER (RFI)
K062416 · HKI
Optical Imaging , Ltd.
Ophthalmic · 92d
Cleared Nov 14, 2006
IRIDEX WIRELESS FOOTSWITCH
K062074 · HQF
Iridex Corp
Ophthalmic · 116d
Cleared Nov 14, 2006
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC...
K062262 · LPL
Ciba Vision Corporation
Ophthalmic · 102d
Cleared Nov 08, 2006
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K062930 · NCF
Alcon Research, Ltd.
Ophthalmic · 41d
Cleared Nov 07, 2006
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D,...
K052599 · HLJ
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 412d
Cleared Nov 06, 2006
CRYOMATIC
K062412 · HRN
Keeler Instruments, Inc.
Ophthalmic · 81d
Cleared Nov 01, 2006
KOWA VX-10I
K062021 · HKI
Kowa Co. , Ltd.
Ophthalmic · 107d
Cleared Nov 01, 2006
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K062548 · HQD
Contamac, Ltd.
Ophthalmic · 63d
Cleared Nov 01, 2006
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED...
K062614 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 57d
Cleared Oct 31, 2006
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
K063191 · OBO
Heidelberg Engineering
Ophthalmic · 11d
Cleared Oct 20, 2006
IRI INTEGRATED RETINAL IMAGER
K062295 · HKI
Medivision Medical Imaging, Ltd.
Ophthalmic · 74d
Cleared Oct 13, 2006
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
K062895 · MPA
Dutch Ophthalmic Research Center...
Ophthalmic · 16d
Cleared Oct 06, 2006
RTVUE
K062552 · OBO
Optovue, Inc.
Ophthalmic · 37d
Cleared Sep 28, 2006
MP-1 MICROPERIMETER
K061768 · HKI
Nidek Technologies Srl
Ophthalmic · 97d