FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
625–648 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 20, 2016
Pentacam AXL
K152311 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 159d
Cleared Jan 20, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort...
K153642 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 20, 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K153643 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 15, 2016
Falck Medical Multifunction Tonometer, FAT1
K151491 · HKY
Falck Medical, Inc.
Ophthalmic · 226d
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