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
865–888 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 17, 2012
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
K121187 · HQF
Katalyst Surgical, LLC
Ophthalmic · 151d
Cleared Sep 14, 2012
SUPRA SCAN DELIVERY SYSTEM
K120825 · HQF
Quantel Medical
Ophthalmic · 179d
Cleared Sep 06, 2012
LENSSX LASER SYSTEM
K120732 · HQC
Alcon Lensx, Inc.
Ophthalmic · 181d
Cleared Aug 31, 2012
DACRYOCATH
K113508 · OKS
Armadillo Biomedical, LLC
Ophthalmic · 277d
Cleared Aug 28, 2012
CATALYS PRECISION LASER SYSTEM
K121091 · OOE
Optimedica Corporation
Ophthalmic · 140d
Cleared Aug 23, 2012
AVT NATURASOFT
K121324 · LPL
Advanced Vision Technologies
Ophthalmic · 113d
Cleared Aug 20, 2012
OPTO HYALUS GREEN LASER
K111460 · HQF
Opto Eletronica S/A
Ophthalmic · 452d
Cleared Aug 17, 2012
CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR...
K112373 · LPL
Innova Vision, Inc.
Ophthalmic · 366d
Cleared Aug 09, 2012
CRAWFORD BIOCANALICULUS INTUBATION
K121142 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 115d
Cleared Aug 03, 2012
MASTERKA 40 MASTERKA 35 MASTERKA 30
K113536 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 247d
Cleared Jul 31, 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · OKS
Quest Medical, Inc.
Ophthalmic · 284d
Cleared Jul 31, 2012
VICTUS LASER PLATFORM
K120426 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 169d
Cleared Jul 20, 2012
CAUTERY
K121441 · HQP
Bovie Medical Corporation
Ophthalmic · 66d
Cleared Jul 11, 2012
AC LENS BRANDED CONTACT LENS CASE
K120969 · LRX
Arlington Contact Lens Services,Inc.
Ophthalmic · 103d
Cleared Jul 06, 2012
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
K121030 · LRX
Sacks Holdings, Inc.
Ophthalmic · 92d
Cleared Jun 28, 2012
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92...
K120996 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Jun 21, 2012
VERSAVIT
K121675 · HQE
Synergetics, Inc.
Ophthalmic · 15d
Cleared Jun 18, 2012
CIRRUS PHOTO
K112184 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 326d
Cleared Jun 15, 2012
INFINITI(R) VISION SYSTEM
K120912 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 81d
Cleared Jun 08, 2012
TBD
K120214 · OOE
Lensar, Inc.
Ophthalmic · 136d
Cleared Jun 05, 2012
BAUSCH + LOMB NESOFILCON A CONTACT LENS
K113703 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 172d
Cleared May 31, 2012
NCI SPATULA
K110734 · OTZ
Fischer Surgical, Inc.
Ophthalmic · 442d
Cleared May 30, 2012
PROCARE PLUS VITRECTOMY SYSTEM
K120170 · HQE
Visioncare Devices, Inc.
Ophthalmic · 132d
Cleared May 25, 2012
OPTOS ADVANCE
K113696 · NFJ
Optos Plc.
Ophthalmic · 161d