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
409–432 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 21, 2018
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES...
K181454 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 170d
Cleared Nov 20, 2018
Orbit Subretinal Delivery System
K182274 · FMF
Orbit Biomedical, Inc.
Ophthalmic · 90d
Cleared Nov 13, 2018
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38...
K182674 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 48d
Cleared Nov 09, 2018
Catalys Precision Laser System
K182083 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 99d
Cleared Nov 02, 2018
Afina
K181501 · NFJ
Neurovision Imaging, LLC
Ophthalmic · 148d
Cleared Nov 01, 2018
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
K182523 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 49d
Cleared Oct 25, 2018
Endocular Viewing Lenses and Silicone Ring
K173944 · HJK
Phakos
Ophthalmic · 303d
Cleared Oct 24, 2018
Retina Workplace
K182318 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 58d
Cleared Oct 22, 2018
Nutrifill
K181566 · MRC
Contamac, Ltd.
Ophthalmic · 130d
Cleared Oct 18, 2018
Spectralis HRA+OCT and variants with High Magnification Module
K182569 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 30d
Cleared Oct 12, 2018
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted,...
K182247 · LPL
Vizionfocus, Inc.
Ophthalmic · 53d
Cleared Sep 28, 2018
RightEye Vision System
K181771 · GWN
Righteye, LLC
Ophthalmic · 87d
Cleared Sep 28, 2018
Harmony
K182376 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 28d
Cleared Sep 19, 2018
Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact...
K181349 · LPL
Visco Vision, Inc.
Ophthalmic · 121d
Cleared Sep 13, 2018
Spectralis HRA+OCT and variants with OCT Angiography Module
K181594 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 87d
Cleared Sep 07, 2018
RetCam 3
K182263 · HKI
Natus Medical Incorporated
Ophthalmic · 17d
Cleared Sep 06, 2018
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors...
K181558 · LPL
Gelflex Laboratories
Ophthalmic · 85d
Cleared Sep 05, 2018
Iridex TruFocus LIO Premiere
K181662 · GEX
Iridex Corporation
Ophthalmic · 72d
Cleared Aug 30, 2018
Spectralis HRA + OCT and variants
K173648 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 276d
Cleared Aug 24, 2018
IOLMaster 700
K173771 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 256d
Cleared Aug 10, 2018
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One...
K181627 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 51d
Cleared Aug 09, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430 · OOE
Lensar, Inc.
Ophthalmic · 69d
Cleared Aug 03, 2018
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook...
K181796 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Jul 27, 2018
RetiCapture
K173474 · HKI
Ilooda Co,., Ltd.
Ophthalmic · 260d