FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
121–144 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 08, 2024
HP-OCT (HP-OCT)
K231760 · HJO
Cylite Pty. , Ltd.
Ophthalmic · 266d
Cleared Mar 08, 2024
RESCAN 700
K233421 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 150d
Cleared Mar 01, 2024
IMAGEnet6 Ophthalmic Data System
K232828 · NFJ
Topcon Corporation
Ophthalmic · 170d
Cleared Feb 26, 2024
Stellaris Elite vision enhancement system
K232084 · HQC
Bausch and Lomb
Ophthalmic · 228d
Cleared Feb 21, 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K233325 · HQD
Visionary Optics, LLC
Ophthalmic · 145d
Cleared Feb 09, 2024
CATS-L Tonometer™ Prism
K234037 · HKY
Cats Tonometer, LLC
Ophthalmic · 50d
Cleared Feb 06, 2024
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K233221 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 131d
Cleared Jan 25, 2024
MR Q
K232417 · HQF
Meridian AG
Ophthalmic · 167d
Cleared Jan 25, 2024
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable...
K234127 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Jan 10, 2024
Centurion™ Vision System (Active Sentry™) (8065753057)
K233902 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 03, 2024
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA...
K223397 · LPL
Hoya Lamphun , Ltd.
Ophthalmic · 421d
Cleared Dec 29, 2023
Precision1
K233856 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 24d
Cleared Dec 27, 2023
TearCare MGX System
K231084 · ORZ
Sight Sciences, Inc.
Ophthalmic · 254d
Cleared Dec 21, 2023
CALLISTO eye
K232944 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared Dec 20, 2023
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens...
K223585 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 384d
Cleared Dec 08, 2023
Eagle device
K230722 · HQF
Belkin Vision, Ltd.
Ophthalmic · 267d
Cleared Dec 07, 2023
RM Electrode (RMH 23-01)
K232273 · HLZ
Retmap, Inc.
Ophthalmic · 129d
Cleared Dec 05, 2023
Optina-4C (MHRC-C1N)
K231230 · HKI
Optina Diagnostics, Inc.
Ophthalmic · 221d
Cleared Nov 20, 2023
Zilia Ocular FC (ZIL-10002)
K230627 · HKI
Zilia, Inc.
Ophthalmic · 259d
Cleared Nov 20, 2023
Harmony
K232555 · NFJ
Topcon Healthcare Solutions
Ophthalmic · 89d
Cleared Nov 17, 2023
Samfilcon B Custom Contact Lens
K230954 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 227d
Cleared Nov 16, 2023
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K232139 · LPL
Innova Vision, Inc.
Ophthalmic · 121d
Cleared Nov 16, 2023
DAILIES TOTAL1®
K232921 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 58d
Cleared Nov 08, 2023
VS Tabletop Tonometer
K223739 · HKX
Medimaging Integrated Solution, Inc.
Ophthalmic · 329d