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
505–528 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 19, 2017
VICTUS Femtosecond Laser Platform
K171014 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 198d
Cleared Oct 18, 2017
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear...
K171125 · LPL
Tangible Science, LLC
Ophthalmic · 184d
Cleared Oct 17, 2017
Applanation tonometer AT-1
K172728 · HKY
Takagi Seiko Co., Ltd.
Ophthalmic · 36d
Cleared Oct 06, 2017
Digital Eye Anterior Camera
K170470 · HJO
Medimaging Integrated Solution, Inc...
Ophthalmic · 232d
Cleared Sep 27, 2017
Cetus system, Cetus probe
K170183 · HQE
A.R.C Laser GmbH
Ophthalmic · 247d
Cleared Sep 20, 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
K172314 · HQD
Art Optical Contact Lens, Inc.
Ophthalmic · 50d
Cleared Sep 18, 2017
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K170286 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 231d
Cleared Sep 15, 2017
Phoenix Clinical ICON
K170527 · HKI
Phoenix Technology Group, Inc. Dba...
Ophthalmic · 205d
Cleared Sep 06, 2017
MicroSTAAR Injector System Cartridges
K172375 · MSS
STAAR Surgical Company
Ophthalmic · 30d
Cleared Aug 25, 2017
Catalys Precision Laser System
K172002 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 53d
Cleared Aug 16, 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K171950 · HQD
Visionary Optics, LLC
Ophthalmic · 48d
Cleared Aug 10, 2017
LENSAR Laser System – fs 3D (LLS-fs 3D)
K171337 · OOE
Lensar, Inc.
Ophthalmic · 94d
Cleared Aug 09, 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES...
K172066 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 33d
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