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
985–1008 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 27, 2010
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K101935 · HKI
Centervue S.P.A.
Ophthalmic · 107d
Cleared Oct 18, 2010
LENSX LASER SYSTEM
K101626 · OOE
Lensx Lasers, Inc.
Ophthalmic · 131d
Cleared Oct 01, 2010
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA,...
K101223 · OBO
Heidelberg Engineering
Ophthalmic · 151d
Cleared Sep 30, 2010
P200MAAF
K102492 · MYC
Optos Plc.
Ophthalmic · 30d
Cleared Sep 15, 2010
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
K093254 · LPN
Abbott Medical Optics, Inc.
Ophthalmic · 334d
Cleared Sep 15, 2010
RTVUE MODEL RTVUE 100
K101505 · HLI
Optovue, Inc.
Ophthalmic · 106d
Cleared Sep 14, 2010
INTELLIWAVE3
K100221 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 231d
Cleared Sep 10, 2010
STERILE SALINE SOLUTION
K093367 · LPN
Cachet Pharmaceuticals Pvt. , Ltd.
Ophthalmic · 316d
Cleared Aug 17, 2010
STELLARIS PC VISION ENHANCEMENT SYSTEM
K101325 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 97d
Cleared Aug 09, 2010
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
K101122 · LPL
Benz Research and Development Corp.
Ophthalmic · 110d
Cleared Aug 09, 2010
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
K101134 · MSS
Medicel AG
Ophthalmic · 109d
Cleared Jul 16, 2010
MEDIWORKS SLIT LAMP
K100439 · HJO
Shanghai Mediworks Precision...
Ophthalmic · 149d
Cleared Jul 15, 2010
OPTOS LIMITED PANORAMIC 200CAF
K100644 · MYC
Optos Plc.
Ophthalmic · 132d
Cleared Jul 08, 2010
VISUMAX LASER KERATOME
K100253 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 161d
Cleared Jun 25, 2010
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP...
K091327 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 416d
Cleared Jun 17, 2010
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
K100861 · HLI
Optovue, Inc.
Ophthalmic · 83d
Cleared May 27, 2010
MAIA, MODEL 1
K092187 · HPT
Centervue S.P.A.
Ophthalmic · 310d
Cleared May 21, 2010
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
K100349 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 98d
Cleared May 13, 2010
LENSAR LASER SYSTEM
K090633 · OOE
Lensar, Inc.
Ophthalmic · 430d
Cleared May 10, 2010
CENTRAL VISION ANALYZER MODEL 1000
K100095 · HOX
Vimetrics,Llc.
Ophthalmic · 117d
Cleared May 04, 2010
PASCAL STREAMLINE PHOTOCOAGULATOR
K100019 · HQF
Optimedica Corporation
Ophthalmic · 119d
Cleared Apr 27, 2010
POLARIS CONTACT LENS CASE
K093377 · LRX
Reliance Design & Manufacturing Corp.
Ophthalmic · 180d
Cleared Apr 23, 2010
LENSX 550 LASER SYSTEM. MODEL 550
K094052 · OOE
Lensx Lasers, Inc.
Ophthalmic · 113d
Cleared Apr 22, 2010
IVUE, MODEL 100
K091404 · OBO
Optovue, Inc.
Ophthalmic · 345d