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
409–432 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 09, 2019
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
K183200 · MUW
C&E GP Specialist, Inc.
Ophthalmic · 51d
Cleared Jan 04, 2019
BostonSight Scleral
K183175 · HQD
Bostonsight
Ophthalmic · 49d
Cleared Jan 02, 2019
NFC-700 non-mydriatic auto fundus camera
K182199 · HKI
Crystalvue Medical Corporation
Ophthalmic · 141d
Cleared Dec 21, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K182795 · OOE
Lensar, Inc.
Ophthalmic · 81d
Cleared Dec 21, 2018
3nethra neo
K183059 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 49d
Cleared Dec 14, 2018
Tono Vue Non-Contact Tonometer
K180820 · HKX
Crystalvue Medical Corporation
Ophthalmic · 260d
Cleared Dec 11, 2018
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens...
K181920 · LPL
CooperVision, Inc.
Ophthalmic · 146d
Cleared CT Dec 11, 2018
Precision1
K182902 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 56d
Cleared Dec 10, 2018
Applanation tonometer AT-2
K182491 · HKY
Takagi Seiko Co., Ltd.
Ophthalmic · 90d
Cleared Dec 10, 2018
LipiScan Dynamic Meibomian Imager
K182506 · HKI
Tearscience, Inc.
Ophthalmic · 89d
Cleared Nov 30, 2018
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K182249 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 102d
Cleared Nov 23, 2018
Hyper GP (tisilfocon A) Daily Wear Contact Lens
K182304 · HQD
Contamac, Ltd.
Ophthalmic · 91d
Cleared Nov 22, 2018
Sunkingdom Slit Lamp
K182306 · HJO
Chongqing Sunkingdom Medical...
Ophthalmic · 90d
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