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
601–624 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 12, 2016
LSFG-NAVI
K153239 · HKI
Softcare Co., Ltd.
Ophthalmic · 185d
Cleared May 11, 2016
Slit Lamp Microscope
K152429 · HJO
Shanghai Mediworks Precision...
Ophthalmic · 259d
Cleared May 06, 2016
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT,...
K152205 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 274d
Cleared May 02, 2016
Green Laser Photocoagulator GYC-500
K152603 · HQF
Nidek Co., Ltd.
Ophthalmic · 234d
Cleared May 02, 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR...
K160609 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 60d
Cleared Apr 29, 2016
Bi-Blade Vitrectomy Cutter
K153168 · HQE
Medical Instrument Development...
Ophthalmic · 179d
Cleared Apr 27, 2016
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
K152724 · HQD
Advanced Vision Technologies
Ophthalmic · 218d
Cleared Apr 27, 2016
Dual Pump Pack
K160236 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 86d
Not Cleared Apr 20, 2016
GLAUCOMA COMPANION
DEN140022 · PLX
Innovatex, Inc.
Ophthalmic · 642d
Cleared Apr 19, 2016
Icare ic100
K153694 · HKY
Icare Finland OY
Ophthalmic · 118d
Cleared Apr 15, 2016
Applanation Tonometer
K142263 · HKY
Shanghai Mediworks Precision...
Ophthalmic · 610d
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 Mar 28, 2016
ACUVUE (senofilcon C) Soft Contact Lens
K160212 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 59d
Cleared 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