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
505–528 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 08, 2017
Ahmed Glaucoma Valve Model FP8
K171451 · KYF
New World Medical, Inc.
Ophthalmic · 83d
Cleared Aug 01, 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
K171077 · HQD
Contamac, Ltd.
Ophthalmic · 112d
Cleared Jul 27, 2017
VISCO 360 Viscosurgical System
K171905 · MRH
Sight Sciences, Inc.
Ophthalmic · 31d
Cleared Jul 25, 2017
Easyret
K170067 · HQF
Quantel Medical
Ophthalmic · 197d
Cleared Jul 21, 2017
Portable Slit Lamp Microscope
K162778 · HJO
Suzhou Kangjie Medical, Inc.
Ophthalmic · 294d
Cleared Jul 17, 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
K171404 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 66d
Cleared Jul 14, 2017
Contact Lens Case
K171539 · LRX
E-Link Plastic & Metal Industrial...
Ophthalmic · 49d
Cleared Jun 27, 2017
Contact Lens Case Round Glasses
K171163 · LRX
Fiftytwoways, Ltd.
Ophthalmic · 68d
Cleared Jun 23, 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
K170302 · HQF
Nidek Co., Ltd.
Ophthalmic · 143d
Cleared Jun 21, 2017
PRIMUS
K163195 · OBO
Carl Zeiss Suzhou Co., Ltd.
Ophthalmic · 218d
Cleared Jun 21, 2017
Retina Workplace
K170638 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 111d
Cleared Jun 15, 2017
Katalyst Cyclophotocoagulation Probe
K163632 · LQJ
Katalyst Surgical, LLC
Ophthalmic · 175d
Cleared Jun 09, 2017
iVue
K163475 · OBO
Optovue, Inc.
Ophthalmic · 179d
Cleared Jun 06, 2017
Altomed Malhotra Platinum Segments
K170591 · MML
Altomed Limited
Ophthalmic · 98d
Cleared Jun 02, 2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
K170001 · HQD
Acuity Polymers, Inc.
Ophthalmic · 150d
Cleared Jun 02, 2017
Zepto
K170655 · PUL
Mynosys Cellular Devices, Inc.
Ophthalmic · 91d
Cleared Jun 02, 2017
PolyDev Soft Contact Lenses
K171157 · LPL
Polydev , Ltd.
Ophthalmic · 43d
Cleared May 31, 2017
SL 220
K162684 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared May 31, 2017
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
K170007 · HQD
Acuity Polymers, Inc.
Ophthalmic · 148d
Cleared May 19, 2017
SLIT LAMP SL-2000
K163564 · HJO
Nidek Co., Ltd.
Ophthalmic · 151d
Cleared May 19, 2017
Catalys Precision Laser System
K170322 · OOE
Abbott Medical Optics, Inc.
Ophthalmic · 107d
Cleared May 05, 2017
LENSAR Laser System - fs 3D (LLS-fs 3D)
K170576 · OOE
Lensar, Inc.
Ophthalmic · 67d
Cleared May 03, 2017
PHAKOS Disposable Retinal Cryo Probe
K162756 · HRN
Phakos
Ophthalmic · 215d
Cleared May 02, 2017
AXIS Image Management System
K171098 · NFJ
Sonomed, Inc.
Ophthalmic · 19d