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
481–504 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared CT Feb 28, 2018
P200TE
K173707 · OBO
Optos Plc.
Ophthalmic · 86d
Cleared Feb 23, 2018
Ophthalmic Software Platform RX
K173689 · NFJ
Canon Inc. -Medical Equipment Group
Ophthalmic · 84d
Cleared Feb 22, 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · LPL
Menicon Co, Ltd.
Ophthalmic · 51d
Cleared CT Jan 19, 2018
EM-4000 Specular Microscope
K171313 · NQE
Tomey Corporation
Ophthalmic · 260d
Cleared CT Jan 19, 2018
DRI OCT Triton
K173119 · OBO
Topcon Corporation
Ophthalmic · 112d
Cleared Dec 26, 2017
iLux Instrument, iLux Disposable
K172645 · ORZ
Tear Film Innovations, Inc.
Ophthalmic · 116d
Cleared Dec 21, 2017
SLM-1ER, SLM-2ER, SLM-3ER
K171877 · HJO
Chongqing Kanghua Ruiming S&T Co., Ltd.
Ophthalmic · 181d
Cleared Dec 21, 2017
OMNI Surgical System
K173332 · MRH
Sight Sciences, Inc.
Ophthalmic · 59d
Cleared Dec 15, 2017
pioli IOL Delivery System
K172228 · MSS
Ast Products, Inc.
Ophthalmic · 143d
Cleared Dec 13, 2017
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic)...
K172692 · LPL
Tangible Science, LLC
Ophthalmic · 98d
Cleared Dec 11, 2017
Crystalsert Lens Delivery System
K173480 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared Dec 05, 2017
OxyPure Color Silicone Hydrogel Soft Contact Lenses
K171447 · LPL
Visco Vision, Inc.
Ophthalmic · 203d
Cleared Dec 04, 2017
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K173538 · LRX
Alcon Laboratories, Inc.
Ophthalmic · 19d
Cleared Nov 30, 2017
Contact Lens Case, Model: A-1, B-1
K172925 · LRX
P L Overseas Limited
Ophthalmic · 66d
Cleared CT 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