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
625–648 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 08, 2016
EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear,...
K153305 · LPL
Eyeyon Medical
Ophthalmic · 144d
Cleared Apr 08, 2016
Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear,...
K153766 · LPL
INTEROJO, Inc.
Ophthalmic · 100d
Cleared CT Mar 28, 2016
ACUVUE (senofilcon C) Soft Contact Lens
K160212 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 59d
Cleared CT Mar 17, 2016
Specular Microscope CEM- 530
K151706 · NQE
Nidek Co., Ltd.
Ophthalmic · 267d
Cleared Mar 04, 2016
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
K151847 · LPL
Smart Performer Corp. , Ltd.
Ophthalmic · 241d
Not Cleared Mar 04, 2016
SENSIMED TRIGGERFISH
DEN140017 · PLZ
Sensimed AG
Ophthalmic · 668d
Cleared Feb 11, 2016
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with...
K151918 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 213d
Cleared Feb 11, 2016
RTVue XR OCT Avanti with AngioVue Software
K153080 · HLI
Optovue, Inc.
Ophthalmic · 111d
Cleared Feb 09, 2016
BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
K153066 · HQD
Boston Foundation For Sight
Ophthalmic · 110d
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 CT 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