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
313–336 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 22, 2020
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448 · MVN
Alcon Laboratories, Inc.
Ophthalmic · 27d
Cleared Sep 18, 2020
Optixon 1-Day
K201013 · LPL
Optixon, Inc.
Ophthalmic · 154d
Cleared Sep 10, 2020
RxSight Contact Lens
K201909 · HJK
Rxsight, Inc.
Ophthalmic · 63d
Cleared Sep 09, 2020
Spectralis HRA+OCT and variants
K201252 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 121d
Cleared CT Sep 08, 2020
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K201194 · HQD
Acuity Polymers, Inc.
Ophthalmic · 127d
Cleared Sep 02, 2020
OCT-Camera ID 21101A3
K200516 · OBO
Optomedical Technologies GmbH
Ophthalmic · 184d
Cleared Sep 01, 2020
VICTUS Femtosecond Laser Platform
K200724 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 166d
Cleared Aug 31, 2020
TrueTear Intranasal Tear Neurostimulator
K193589 · QBR
Allergan
Ophthalmic · 252d
Cleared Aug 21, 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K202036 · MVN
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Aug 11, 2020
LION Photocoagulator
K201623 · HQF
Norlase Aps
Ophthalmic · 57d
Cleared Aug 11, 2020
OMNI PLUS Surgical System
K201953 · MRH
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Aug 06, 2020
Vitra 810
K201502 · HQF
Quantel Medical
Ophthalmic · 62d
Cleared CT Aug 03, 2020
EyeArt
K200667 · PIB
Eyenuk, Inc.
Ophthalmic · 143d
Cleared Aug 03, 2020
Glaucoma Module
K200954 · NFJ
Topcon Healthcare Solutions, Inc.
Ophthalmic · 116d
Cleared Jul 31, 2020
xPORT 304 (miCOR) System Lens Fragmentation System
K200584 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 147d
Cleared Jul 31, 2020
VibrantVue Scleral Saline
K201069 · MRC
Dry Eye Innovations, LLC
Ophthalmic · 100d
Cleared Jul 23, 2020
Canon non-mydriatic retinal camera CR series
K201122 · HKI
Canon, Inc.
Ophthalmic · 87d
Cleared Jul 15, 2020
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens,...
K201080 · LPL
Visco Vision, Inc.
Ophthalmic · 84d
Cleared Jul 14, 2020
Orbit Subretinal Delivery System
K200325 · FMF
Orbit Biomedical
Ophthalmic · 155d
Cleared Jun 17, 2020
Miru 1day UpSide (midafilcon A)
K193399 · LPL
Menicon Co, Ltd.
Ophthalmic · 194d
Cleared Jun 15, 2020
Visalis V500, Visalis S500
K193376 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 193d
Cleared Jun 04, 2020
bioli lOL Delivery System
K200057 · MSS
Ast Products, Inc.
Ophthalmic · 143d
Cleared CT Jun 02, 2020
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A)...
K200528 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 92d
Cleared Jun 02, 2020
MIRA Adapter
K200911 · HRN
Phakos
Ophthalmic · 57d