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
49–72 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 CT 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
Cleared CT 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 CT 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