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
25–48 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 10, 2026
LANDR Contact LENS Case
K252175 · LRX
Fourth Axis, LLC
Ophthalmic · 214d
Cleared Feb 06, 2026
INTEGRE LIO
K251507 · HQF
Quantel Medical
Ophthalmic · 266d
Cleared Jan 16, 2026
Eyer 2
K251353 · HKI
Phelcom Technologies
Ophthalmic · 261d
Cleared Dec 23, 2025
UNITY DX (UDX)
K252633 · OBO
Cylite Pty. , Ltd.
Ophthalmic · 125d
Cleared Dec 23, 2025
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV...
K251683 · LPL
Bruno Vision Care, LLC
Ophthalmic · 207d
Cleared Dec 18, 2025
Tomey Optical Biometer OA-2000 (OA-2000)
K252348 · MXK
Tomey Corporation
Ophthalmic · 142d
Cleared Dec 12, 2025
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · HKI
Remidio Innovative Solutions Private...
Ophthalmic · 158d
Cleared Nov 14, 2025
System Sophi
K250501 · HQC
This AG
Ophthalmic · 267d
Cleared Nov 07, 2025
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
K253039 · HKX
Topcon Corporation
Ophthalmic · 46d
Cleared Oct 29, 2025
Navilas Laser System 577sl (156691)
K251772 · HQF
Od-Os GmbH
Ophthalmic · 141d
Cleared Oct 09, 2025
cleadew GP hydra one
K251876 · MRC
Ophtecs Corporation
Ophthalmic · 113d
Cleared Oct 07, 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)...
K250364 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 239d
Cleared Sep 25, 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens...
K244009 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 273d
Not Cleared Sep 25, 2025
Essilor® Stellest®
DEN250016 · QUR
Essilor of America, Inc.
Ophthalmic · 150d
Cleared Sep 24, 2025
LenSx Laser System (8065000944)
K252682 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Sep 17, 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095 · LPL
Pegavision Corporation
Ophthalmic · 160d
Cleared Sep 16, 2025
ACCUJECT Injector Set 2.1-1P (LP604590)
K252540 · MSS
Medicel AG
Ophthalmic · 35d
Cleared Sep 11, 2025
XTRA4
K251320 · LYX
Al.Chi.Mi.A. S.R.L
Ophthalmic · 135d
Cleared Sep 10, 2025
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
K251573 · LPL
Vizionfocus, Inc.
Ophthalmic · 111d
Cleared Sep 04, 2025
Optina-4C (MHRC-C1N)
K250770 · HKI
Optina Diagnostics, Inc.
Ophthalmic · 175d
Cleared Aug 14, 2025
3nethra neo HD FA
K243600 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 266d
Cleared Aug 08, 2025
MICOR 700 with Auto I/A
K243395 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 281d
Cleared Aug 01, 2025
MINI VP1 (PL67_F)
K250495 · LRX
Avizor S.A.
Ophthalmic · 162d
Cleared Jul 30, 2025
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K242855 · LPL
E.O.S Co., Ltd.
Ophthalmic · 313d