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
601–624 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared May 26, 2016
Z5 Slit lamp microscope, Z2 Slit lamp microscope
K152535 · HJO
Takagi Seiko Co., Ltd.
Ophthalmic · 265d
Cleared CT May 26, 2016
Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy...
K160344 · LPL
Visco Vision, Inc.
Ophthalmic · 108d
Cleared May 17, 2016
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
K152657 · LPL
Smart Performer Corp. , Ltd.
Ophthalmic · 244d
Cleared May 13, 2016
Oasis Lacrimal Intubation Set
K160710 · OKS
Anodyne
Ophthalmic · 59d
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