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
193–216 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 03, 2022
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes,...
K220263 · HQB
Vortex Surgical, Inc.
Ophthalmic · 276d
Cleared Nov 02, 2022
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
K222395 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 86d
Cleared Oct 31, 2022
Excelsior
K220929 · NFJ
Merit Cro, Inc.
Ophthalmic · 214d
Cleared Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · LPN
Chemtex USA, Inc.
Ophthalmic · 163d
Cleared Oct 11, 2022
ECHO Photocoagulator
K222157 · HQF
Norlase
Ophthalmic · 83d
Cleared Oct 06, 2022
iCare IC200
K220852 · HKY
Icare Finland OY
Ophthalmic · 197d
Cleared Oct 05, 2022
Cornisol
K221759 · LYX
Aurolab
Ophthalmic · 110d
Cleared Oct 04, 2022
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR...
K221517 · LPL
INTEROJO, Inc.
Ophthalmic · 132d
Cleared Sep 29, 2022
CureSight-CS100
K221375 · QQU
Novasight , Ltd.
Ophthalmic · 140d
Cleared Sep 15, 2022
AIR OPTIX COLORS
K222500 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Sep 09, 2022
MICOR Lens Fragmentation System
K214028 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d
Cleared Sep 08, 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · LPL
Shenzhen Dashicheng Optical...
Ophthalmic · 233d
Cleared Sep 07, 2022
EyeCTester
K203594 · QTW
Neuro-Eye Diagnostic Systems, LLC
Ophthalmic · 637d
Cleared Sep 02, 2022
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for...
K213983 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 256d
Cleared Aug 29, 2022
Non-Mydriatic Retinal Camera NW500
K221111 · HKI
Topcon Corporation
Ophthalmic · 136d
Cleared Aug 24, 2022
miCOR System Lens Fragmentation System
K222236 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 29d
Cleared Aug 15, 2022
FORUM
K213527 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 284d
Cleared Aug 12, 2022
Visibly Digital Acuity Product
K220090 · QTO
Visibly, Inc.
Ophthalmic · 213d
Cleared Aug 10, 2022
UniVit HE, UniVit UHS
K212763 · HQE
Visioncare Devices, LLC
Ophthalmic · 344d
Cleared Aug 05, 2022
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K220045 · LPL
Dk Medivision Co., Ltd.
Ophthalmic · 212d
Cleared Aug 02, 2022
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · KYF
Glaukos Corporation
Ophthalmic · 209d
Cleared Jul 15, 2022
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
K220877 · HQF
Lumenis Be, Inc.
Ophthalmic · 112d
Cleared Jun 24, 2022
EZYPOR
K212741 · HPZ
Fci (France Chirurgie...
Ophthalmic · 298d
Cleared Jun 23, 2022
ZEPTO Precision Capsulotomy System
K221188 · PUL
Centricity Vision, Inc.
Ophthalmic · 59d