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
721–744 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 18, 2014
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
K141670 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 87d
Cleared Sep 17, 2014
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
K141481 · HKI
Topcon Corporation
Ophthalmic · 105d
Cleared Sep 17, 2014
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
K141638 · HLI
Propper Manufacturing Co., Inc.
Ophthalmic · 90d
Cleared Sep 17, 2014
D-KAT Z-YPE
K142179 · HKY
Keeler, Ltd.
Ophthalmic · 40d
Cleared Sep 15, 2014
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES,...
K140362 · HQF
Katalyst Surgical, LLC
Ophthalmic · 215d
Cleared Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K141079 · OOE
Optimedica Corporation
Ophthalmic · 139d
Cleared Sep 10, 2014
CONTACT LENS CASE
K140488 · LRX
Maca Plastics, Inc.
Ophthalmic · 195d
Cleared Sep 10, 2014
EyeSuite Imaging
K142423 · NFJ
Haag-Streit AG
Ophthalmic · 13d
Cleared Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
K141068 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 138d
Cleared Aug 26, 2014
SLIT LAMP SL-D701
K133667 · HJO
Topcon Corp.
Ophthalmic · 270d
Cleared Aug 22, 2014
CONSTELLATION VISION SYSTEM
K141065 · HQE
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE...
K133358 · HQF
Nidek Co., Ltd.
Ophthalmic · 285d
Cleared Aug 12, 2014
CATARHEX 3
K133562 · HQC
Oertli Instrumente AG
Ophthalmic · 265d
Cleared Jul 18, 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
K141280 · LPL
Seinoh Optical Co. , Ltd.
Ophthalmic · 63d
Cleared CT Jul 15, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K140615 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 127d
Cleared Jul 11, 2014
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP...
K140451 · HJO
Keeler Limited
Ophthalmic · 137d
Cleared Jul 09, 2014
FLENTS PLASTIC EYE WASH CUP
K140409 · LXQ
Apothecary Products, Inc.
Ophthalmic · 141d
Cleared Jul 03, 2014
COBRA FUNDUS CAMERA
K132987 · HKI
C.S.O. S.R.L.
Ophthalmic · 282d
Cleared Jun 25, 2014
OPTIMUS FUSION: SLT, YAG AND YAG/SLT
K140336 · HQF
Quantel Medical
Ophthalmic · 135d
Cleared Jun 20, 2014
DISCOVERY SYSTEM
K133062 · HJO
Innovative Visual Systems
Ophthalmic · 266d
Cleared Jun 20, 2014
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM...
K140711 · LZU
Paragon Bioteck, Inc.
Ophthalmic · 91d
Cleared Jun 17, 2014
KEELER KAPTURE SOFTWARE
K140450 · HKI
Keeler Limited
Ophthalmic · 113d
Cleared CT Jun 11, 2014
OPTICAL BIOMETER AL-SCAN
K133132 · HJO
Nidek Co., Ltd.
Ophthalmic · 254d
Cleared Jun 11, 2014
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT...
K133403 · LPL
Firestone Optics, Inc.
Ophthalmic · 217d