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
481–504 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 30, 2017
Contact Lens Case, Model: A-1, B-1
K172925 · LRX
P L Overseas Limited
Ophthalmic · 66d
Cleared Nov 27, 2017
PSLT for PASCAL Streamline
K171488 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 189d
Cleared Nov 27, 2017
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original...
K173089 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 59d
Cleared Nov 17, 2017
Bausch + Lomb Boston Scleral Lens Case
K173365 · LRX
Bausch & Lomb, Incorporated
Ophthalmic · 22d
Cleared Nov 16, 2017
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
K173136 · MRC
Menicon Co, Ltd.
Ophthalmic · 48d
Cleared Nov 07, 2017
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K173086 · LPL
Visioneering Technologies, Inc.
Ophthalmic · 39d
Cleared Nov 01, 2017
IMAGEnet 6 Ophthalmic Data System
K171370 · NFJ
Topcon Corporation
Ophthalmic · 175d
Cleared Nov 01, 2017
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT,...
K172649 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 57d
Cleared Oct 26, 2017
EPI K Console
K172994 · HNO
Moria SA
Ophthalmic · 29d
Cleared Oct 25, 2017
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
K172600 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 56d
Cleared Oct 24, 2017
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
K171575 · HQD
Contamac, Ltd.
Ophthalmic · 147d
Cleared Oct 19, 2017
VICTUS Femtosecond Laser Platform
K171014 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 198d
Cleared Oct 18, 2017
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear...
K171125 · LPL
Tangible Science, LLC
Ophthalmic · 184d
Cleared Oct 17, 2017
Applanation tonometer AT-1
K172728 · HKY
Takagi Seiko Co., Ltd.
Ophthalmic · 36d
Cleared Oct 06, 2017
Digital Eye Anterior Camera
K170470 · HJO
Medimaging Integrated Solution, Inc...
Ophthalmic · 232d
Cleared Sep 27, 2017
Cetus system, Cetus probe
K170183 · HQE
A.R.C Laser GmbH
Ophthalmic · 247d
Cleared Sep 20, 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
K172314 · HQD
Art Optical Contact Lens, Inc.
Ophthalmic · 50d
Cleared Sep 18, 2017
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K170286 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 231d
Cleared Sep 15, 2017
Phoenix Clinical ICON
K170527 · HKI
Phoenix Technology Group, Inc. Dba...
Ophthalmic · 205d
Cleared Sep 06, 2017
MicroSTAAR Injector System Cartridges
K172375 · MSS
STAAR Surgical Company
Ophthalmic · 30d
Cleared Aug 25, 2017
Catalys Precision Laser System
K172002 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 53d
Cleared Aug 16, 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K171950 · HQD
Visionary Optics, LLC
Ophthalmic · 48d
Cleared Aug 10, 2017
LENSAR Laser System – fs 3D (LLS-fs 3D)
K171337 · OOE
Lensar, Inc.
Ophthalmic · 94d
Cleared Aug 09, 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES...
K172066 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 33d