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
577–600 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Sep 15, 2016
Eusol-C
K162013 · LYX
Al.Chi.Mi.A. S.R.L
Ophthalmic · 56d
Cleared Aug 26, 2016
EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
K161124 · LPL
Vision Science Co., Ltd.
Ophthalmic · 127d
Cleared Aug 22, 2016
ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
K161098 · LPL
Joowon Innovation Co., Ltd.
Ophthalmic · 125d
Cleared Aug 11, 2016
SACCADOMETER PLUS, SACCADOMETER ADVANCED
K152890 · HLL
Ober Consulting Sp. Z.O.O.
Ophthalmic · 316d
Cleared Aug 11, 2016
LensGiene Sterile Saline Solution
K161622 · LPN
Optics Laboratory, Inc.
Ophthalmic · 59d
Cleared Aug 10, 2016
Hidrocor, Hidrocharme, and Natural Colors
K160472 · LPL
Solotica
Ophthalmic · 173d
Cleared Aug 10, 2016
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
K161100 · HQD
Contamac, Ltd.
Ophthalmic · 113d
Cleared Aug 01, 2016
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily...
K160938 · HQD
Synergeyes, Inc.
Ophthalmic · 119d
Cleared Jul 28, 2016
3D OCT-1 Maestro
K161509 · OBO
Topcon Corporation
Ophthalmic · 57d
Cleared Jul 25, 2016
BostonSight PD Prosthetic Device
K161461 · HQD
Bostonsight
Ophthalmic · 60d
Cleared Jul 13, 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · LPL
CooperVision, Inc.
Ophthalmic · 112d
Cleared Jul 13, 2016
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
K160859 · MUW
Contamac, Ltd.
Ophthalmic · 106d
Cleared Jul 13, 2016
PolyDev Soft Contact Lenses
K160977 · LPL
Polydev , Ltd.
Ophthalmic · 97d
Cleared Jul 06, 2016
Easy-Load Lens Delivery System
K161012 · MSS
Bausch and Lomb, Inc.,
Ophthalmic · 86d
Cleared Jun 22, 2016
Portable Slit Lamp
K153545 · HJO
Shanghai Bolan Optical-Electric Co.,...
Ophthalmic · 194d
Cleared Jun 15, 2016
LightLas Multi-Wavelength Medical Laser System
K152688 · HQF
Lightmed Corporation
Ophthalmic · 271d
Cleared Jun 08, 2016
MAIA
K153181 · MYC
Centervue S.P.A.
Ophthalmic · 218d
Not Cleared Jun 08, 2016
PEDIATRIC VISION SCANNER
DEN130051 · PMW
Rebiscan, Inc.
Ophthalmic · 908d
Cleared Jun 07, 2016
Contact Lens Case (multiple brand name)
K160005 · LRX
Danyang Chanxin Glasses Cases Factory
Ophthalmic · 155d
Cleared Jun 06, 2016
MICROPERIMETER MP-3
K152729 · HKI
Nidek Co., Ltd.
Ophthalmic · 258d