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
577–600 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 04, 2016
LipiFlow Thermal Pulsation System
K161357 · ORZ
Tearscience, Inc.
Ophthalmic · 172d
Cleared Nov 03, 2016
Nunchaku
K161373 · OKS
Fci (France Chirurgie Instrumentation)
Ophthalmic · 170d
Cleared Oct 26, 2016
PLEX Elite 9000 SS-OCT
K161194 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 182d
Cleared Oct 24, 2016
Visco (olifilcon A) soft contact lens
K160245 · LPL
Visco Vision, Inc.
Ophthalmic · 266d
Cleared Oct 24, 2016
Ahmed Glaucoma Valve
K162060 · KYF
New World Medical, Inc.
Ophthalmic · 90d
Cleared Oct 21, 2016
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens,...
K162317 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 63d
Cleared Oct 19, 2016
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K162597 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Oct 13, 2016
AIR OPTIX COLORS
K162596 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 27d
Cleared Oct 12, 2016
Toricolors (hioxifilcon D) Soft Contact Lenses
K161931 · LPL
Polydev , Ltd.
Ophthalmic · 90d
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 CT 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 CT 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 CT Jul 13, 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · LPL
CooperVision, Inc.
Ophthalmic · 112d