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
553–576 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 09, 2016
Slit Lamp SL-D301
K161972 · HJO
Topcon Corporation
Ophthalmic · 144d
Cleared Dec 09, 2016
EnFocus 2300, EnFocus 4400
K162783 · OBO
Bioptigen, Inc.
Ophthalmic · 67d
Cleared Dec 09, 2016
Contact Lens Case
K162869 · LRX
Ningbo Yinzhou Zonghai Artware Co., Ltd.
Ophthalmic · 57d
Cleared Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K162005 · HQD
Acuity Polymers, Inc.
Ophthalmic · 141d
Cleared Nov 30, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal,...
K161391 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 195d
Cleared Nov 29, 2016
Lenstec LC Injection system
K161776 · MSS
Lenstec, Inc.
Ophthalmic · 153d
Cleared Nov 25, 2016
NNR06 Multi-Purpose Solution
K161819 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 147d
Cleared Nov 21, 2016
XEN Glaucoma Treatment System
K161457 · KYF
Allergan, Inc.
Ophthalmic · 179d
Cleared Nov 18, 2016
LacriPro Punctum Plug
K161673 · LZU
Lacrimedics, Inc.
Ophthalmic · 155d
Cleared Nov 16, 2016
LenSX Laser System
K161288 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 191d
Cleared Nov 15, 2016
SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact...
K153714 · HQD
Synergeyes, Inc.
Ophthalmic · 327d
Cleared Nov 04, 2016
LipiFlow Thermal Pulsation System
K161357 · ORZ
Tearscience, Inc.
Ophthalmic · 172d
Cleared Nov 03, 2016
Nunchaku
K161373 · OKS
Fci (France Chirurgie Instrumentation)
Ophthalmic · 170d
Cleared Oct 26, 2016
PLEX Elite 9000 SS-OCT
K161194 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 182d
Cleared Oct 24, 2016
Visco (olifilcon A) soft contact lens
K160245 · LPL
Visco Vision, Inc.
Ophthalmic · 266d
Cleared Oct 24, 2016
Ahmed Glaucoma Valve
K162060 · KYF
New World Medical, Inc.
Ophthalmic · 90d
Cleared Oct 21, 2016
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens,...
K162317 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 63d
Cleared Oct 19, 2016
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K162597 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Oct 13, 2016
AIR OPTIX COLORS
K162596 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 27d
Cleared Oct 12, 2016
Toricolors (hioxifilcon D) Soft Contact Lenses
K161931 · LPL
Polydev , Ltd.
Ophthalmic · 90d
Cleared Oct 05, 2016
R:GEN Laser System
K153769 · HQF
Lutronic Corporation
Ophthalmic · 280d
Cleared Oct 05, 2016
ALADDIN HW3.0
K160327 · HJO
Visia Imaging S.R.L.
Ophthalmic · 243d
Cleared Oct 04, 2016
Eyenez Ophthalmic Camera
K161727 · HKI
Eyenez, LLC
Ophthalmic · 104d
Cleared Sep 20, 2016
Catalys Precision Laser System
K161455 · OOE
Optimedica Corporation
Ophthalmic · 117d