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
625–648 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 14, 2016
LipiView II Ocular Surface Interferometer
K152869 · HKI
Tearscience, Inc.
Ophthalmic · 106d
Cleared Dec 31, 2015
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
K152644 · HKY
Keeler Limited
Ophthalmic · 106d
Cleared Dec 24, 2015
BrainPort V100
K152851 · PIC
Wicab, Inc.
Ophthalmic · 86d
Cleared Dec 17, 2015
Molteno3 Glaucoma Implant
K152996 · KYF
Innovative Ophthalmic Products, Inc....
Ophthalmic · 65d
Cleared Dec 02, 2015
EnFocus 2300, EnFocus 4400
K150722 · HLI
Bioptigen, Inc.
Ophthalmic · 257d
Cleared Nov 24, 2015
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens...
K152046 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 124d
Cleared Oct 30, 2015
MicroSTAAR Injector System Cartridges
K152357 · KYB
STAAR Surgical Company
Ophthalmic · 71d
Cleared Oct 23, 2015
FEMTO LDV Z8 Surgical Laser
K150323 · OOE
Sie Ag,Surgical Instrument Engineering
Ophthalmic · 256d
Cleared Oct 19, 2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature...
K151636 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 124d
Cleared Oct 15, 2015
LENSAR Laser System - fs 3D (LLS-fs 3D)
K152453 · OOE
Lensar, Inc.
Ophthalmic · 48d
Cleared Oct 13, 2015
Sensor Medical Single Use Tonometer Prism
K152308 · HKY
Sensor Medical Technology, LLC
Ophthalmic · 60d
Cleared Oct 02, 2015
ARGOS
K150754 · MXK
Santec Corporation
Ophthalmic · 193d
Cleared Oct 01, 2015
Synergy ODM
K151952 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 78d
Cleared Sep 11, 2015
23ga Chandelier Illuminator, 25ga Chandelier Illuminator
K151604 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Sep 10, 2015
Keeler Slit Lamp
K151394 · HJO
Keeler Limited
Ophthalmic · 107d
Cleared Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
K151783 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 63d
Cleared Sep 01, 2015
CIRRUS HD-OCT
K150977 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 141d
Cleared Sep 01, 2015
Dynarex Eye Cups
K151575 · LXQ
Dynarex Corporation
Ophthalmic · 82d
Cleared Aug 28, 2015
PDO Absorbable Punctum Plug
K150288 · LZU
Riverpoint Medical
Ophthalmic · 204d
Cleared Aug 28, 2015
Menicon Saline Rinse Solution
K151768 · LPN
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Aug 18, 2015
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K151961 · HJK
Volk Optical, Inc.
Ophthalmic · 33d
Cleared Aug 17, 2015
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986 · MML
Meddev Corporation
Ophthalmic · 125d
Cleared Aug 10, 2015
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
K151586 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 60d
Cleared Aug 06, 2015
Cornea Cold
K151061 · LYX
Eurobio
Ophthalmic · 108d