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
73–96 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 15, 2025
TearCare MGX System
K242786 · ORZ
Sight Sciences, Inc.
Ophthalmic · 211d
Cleared Apr 10, 2025
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
K243953 · LPL
Vizionfocus, Inc.
Ophthalmic · 108d
Cleared CT Apr 09, 2025
Luminopia
K243819 · QQU
Luminopia, Inc.
Ophthalmic · 118d
Cleared Apr 03, 2025
Leos Laser and Endoscopy System
K240615 · HQF
Beaver-Visitec International, Inc.
Ophthalmic · 394d
Cleared Mar 20, 2025
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
K241884 · LPL
Hunan Haipuming Technology Co., Ltd.
Ophthalmic · 265d
Cleared Mar 17, 2025
MAIA (AHMACME001)
K243504 · MYC
Centervue S.P.A.
Ophthalmic · 125d
Cleared Feb 14, 2025
VIA360™ Surgical System
K243503 · MRH
New World Medical, Inc.
Ophthalmic · 94d
Cleared Feb 04, 2025
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
K242916 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 133d
Cleared Jan 13, 2025
Precision1
K243909 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 25d
Cleared Dec 17, 2024
Sentinel Camera
K243664 · HKI
Ai Optics
Ophthalmic · 20d
Cleared Dec 17, 2024
VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily...
K242413 · LPL
Vizionfocus, Inc.
Ophthalmic · 125d
Cleared Dec 16, 2024
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric...
K232839 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 459d
Cleared Dec 13, 2024
Anterion
K240924 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 253d
Cleared Dec 09, 2024
Verily Numetric Retinal Camera
K242508 · HKI
Verily Life Sciences, LLC
Ophthalmic · 109d
Cleared Dec 04, 2024
Alcon 27GA Chandelier (8065000252)
K242184 · MPA
Alcon Laboratories, Inc.
Ophthalmic · 132d
Cleared CT Nov 04, 2024
Tixel i (TXLI0001)
K240512 · ORZ
Novoxel , Ltd.
Ophthalmic · 256d
Not Cleared Nov 04, 2024
Valeda Light Delivery System
DEN230083 · SDE
Lumithera, Inc.
Ophthalmic · 326d
Cleared Nov 01, 2024
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™...
K242393 · HQD
Acuity Polymers, Inc.
Ophthalmic · 80d
Cleared Oct 25, 2024
LYNX Photocoagulator
K242397 · HQF
Norlase Aps
Ophthalmic · 73d
Cleared CT Oct 25, 2024
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV...
K240918 · LPL
Bruno Vision Care, LLC
Ophthalmic · 205d
Cleared Oct 22, 2024
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
K241398 · HQD
Tianjin Mastervision Technology Co.,...
Ophthalmic · 159d
Cleared Oct 21, 2024
Digital Prism Correction Feature (DPCF)
K242058 · SCW
Apple, Inc.
Ophthalmic · 98d
Cleared CT Oct 11, 2024
SPECTRALIS with Flex Module
K241163 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 168d
Cleared Oct 10, 2024
EyeGility™ Inserter for Preloaded enVista IOLs
K242389 · MSS
Bausch & Lomb, Incorporated
Ophthalmic · 59d