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
865–888 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 26, 2012
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
K121201 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 190d
Cleared Oct 25, 2012
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT,...
K121993 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 111d
Cleared Oct 19, 2012
LACRICATH LACRIMAL DUCT CATHETER
K113867 · OKS
Quest Medical, Inc.
Ophthalmic · 294d
Cleared Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K121721 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 125d
Cleared Oct 05, 2012
CVUE ADVANCED HYDRA VUE
K121652 · LPL
Unilens Corp., USA
Ophthalmic · 122d
Cleared Oct 03, 2012
EK DELIVERY DEVICE
K121579 · OTZ
Tdak Medical, Inc.
Ophthalmic · 126d
Cleared Sep 28, 2012
BAUSCH & LOMB IOL INJECTOR
K113852 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 274d
Cleared Sep 28, 2012
DIGITAL EYE-FUNDUS CAMERA
K120982 · HKI
Medimaging Integrated Solutions, Inc....
Ophthalmic · 179d
Cleared Sep 18, 2012
ISIGHT
K121519 · LPL
C&E GP Specialists, Inc.
Ophthalmic · 119d
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