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
49–72 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 18, 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
K250553 · OBO
Tomey Corporation
Ophthalmic · 143d
Cleared Jul 02, 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K243868 · LPL
Pegavision Corporation
Ophthalmic · 197d
Cleared Jun 23, 2025
Digital Prism Correction Feature (DPCF)
K250143 · SCW
Apple, Inc.
Ophthalmic · 157d
Cleared Jun 18, 2025
EyeQ nanoECP
K243014 · HQF
Eyeq, Inc.
Ophthalmic · 264d
Cleared Jun 11, 2025
MICOR 700 System (N/A)
K242801 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 267d
Cleared May 12, 2025
SPECTRALIS HRA+OCT and variants
K250868 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 49d
Cleared Apr 30, 2025
Resolve Fundus Camera
K250683 · HKI
Optain Health, Inc.
Ophthalmic · 55d
Cleared Apr 28, 2025
LenSx Laser System (8065998162)
K243896 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 131d
Cleared Apr 22, 2025
OcuMet Beacon (OCUB100)
K241931 · MYC
Ocusciences, Inc.
Ophthalmic · 295d
Cleared Apr 17, 2025
CLARUS (700)
K243878 · QER
Carl Zeiss Meditec, Inc.
Ophthalmic · 120d
Cleared Apr 17, 2025
miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily...
K242056 · LPL
Benq Materials Corporation
Ophthalmic · 276d
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 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