FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,106 results
289–312 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 07, 2020
Ophthalmic Yag Laser System YC-200
K203130 · HQF
Nidek Co., Ltd.
Ophthalmic · 49d
Cleared Nov 20, 2020
Optomed Smartscope M5 with Optomed Smartscope FA
K201325 · HKI
Optomed Oyj
Ophthalmic · 186d
Cleared Oct 21, 2020
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59%...
K201268 · LPL
Plexus Optix, Inc.
Ophthalmic · 162d
Cleared Oct 21, 2020
Pentacam AXL Wave
K201724 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 120d
Cleared Oct 21, 2020
Iridex 810 Laser
K202760 · HQF
Iridex Corporation
Ophthalmic · 30d
Cleared Oct 20, 2020
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1...
K202756 · LPL
CooperVision, Inc.
Ophthalmic · 29d
Cleared Oct 15, 2020
xPORT S Lens Fragmentation System
K200207 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d
Cleared Oct 15, 2020
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact...
K200296 · LPL
Pegavision Corporation
Ophthalmic · 252d
Cleared Sep 25, 2020
ImageSPECTRUM
K201273 · NFJ
Canon, Inc.
Ophthalmic · 136d
Not Cleared Sep 24, 2020
Tangible Boost
DEN200002 · QMM
Tangible Science, Inc.
Ophthalmic · 255d
Cleared Sep 23, 2020
Boston One Step Liquid Enzymatic Cleaner
K200416 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 216d
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 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 Aug 03, 2020
EyeArt
K200667 · PIB
Eyenuk, Inc.
Ophthalmic · 143d