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
433–456 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 CT 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
Cleared Jul 26, 2018
RxSight Insertion Device
K181401 · MSS
Rxsight, Inc.
Ophthalmic · 58d
Cleared Jul 26, 2018
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas...
K181579 · HQD
E&E Optics, Inc.
Ophthalmic · 41d
Cleared Jul 19, 2018
Image Filing Software NAVIS-EX
K181345 · NFJ
Nidek Co., Ltd.
Ophthalmic · 59d
Cleared Jul 16, 2018
EIDON FA
K180526 · MYC
Centervue S.P.A.
Ophthalmic · 139d
Cleared Jul 16, 2018
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K181016 · NFJ
Welch Allyn, Inc.
Ophthalmic · 90d
Cleared Jun 29, 2018
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K181232 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 51d
Cleared Jun 27, 2018
CALLISTO eye
K180858 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 86d
Cleared Jun 27, 2018
Alleye
K180895 · HOQ
Oculocare Medical AG
Ophthalmic · 83d
Cleared Jun 25, 2018
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K181230 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 47d
Cleared Jun 13, 2018
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K181050 · LPL
Qualimed Srl
Ophthalmic · 54d
Cleared Jun 08, 2018
Nexy
K180306 · HKI
Next Sight Srl
Ophthalmic · 126d