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
73–96 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 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 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 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
Cleared Oct 09, 2024
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · LRX
Shanghai Care US Medical Product Co.,...
Ophthalmic · 271d
Cleared Oct 08, 2024
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K242391 · LPL
Lucens Technology Co., Ltd.
Ophthalmic · 57d
Not Cleared Sep 30, 2024
OcuCool
DEN230011 · QZQ
Recensmedical, Inc.
Ophthalmic · 592d
Cleared Sep 27, 2024
iCare ST500 (TA04)
K241447 · HKY
Icare Finland OY
Ophthalmic · 128d
Cleared Sep 06, 2024
VISULAS combi
K233911 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 269d
Cleared Aug 22, 2024
iCare ALTIUS CW
K234076 · NFJ
Centervue S.P.A.
Ophthalmic · 245d
Cleared Aug 16, 2024
BOSS™
K223700 · MXK
Intelon Optics, Inc.
Ophthalmic · 613d
Cleared Aug 14, 2024
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens...
K242059 · LPL
X-Cel Specialty Contacts, A Walman...
Ophthalmic · 30d
Cleared Aug 14, 2024
BostonSight® Specialty Lenses
K241571 · HQD
Boston Foundation For Sight, Inc....
Ophthalmic · 75d
Cleared Aug 08, 2024
Luminopia
K233720 · QQU
Luminopia, Inc.
Ophthalmic · 261d
Cleared Aug 05, 2024
Midfield Light Pipe, 23ga (3269.M06-00)
K233653 · MPA
Peregrine Surgical, LLC
Ophthalmic · 265d
Cleared Jul 26, 2024
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
K240169 · HQC
Bausch and Lomb, Incorporated
Ophthalmic · 186d
Cleared Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · OBO
Topcon Corporation
Ophthalmic · 89d