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
649–672 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 02, 2015
ARGOS
K150754 · MXK
Santec Corporation
Ophthalmic · 193d
Cleared Oct 01, 2015
Synergy ODM
K151952 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 78d
Cleared Sep 11, 2015
23ga Chandelier Illuminator, 25ga Chandelier Illuminator
K151604 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Sep 10, 2015
Keeler Slit Lamp
K151394 · HJO
Keeler Limited
Ophthalmic · 107d
Cleared Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
K151783 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 63d
Cleared Sep 01, 2015
CIRRUS HD-OCT
K150977 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 141d
Cleared Sep 01, 2015
Dynarex Eye Cups
K151575 · LXQ
Dynarex Corporation
Ophthalmic · 82d
Cleared Aug 28, 2015
PDO Absorbable Punctum Plug
K150288 · LZU
Riverpoint Medical
Ophthalmic · 204d
Cleared Aug 28, 2015
Menicon Saline Rinse Solution
K151768 · LPN
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Aug 18, 2015
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K151961 · HJK
Volk Optical, Inc.
Ophthalmic · 33d
Cleared Aug 17, 2015
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986 · MML
Meddev Corporation
Ophthalmic · 125d
Cleared Aug 10, 2015
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
K151586 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 60d
Cleared Aug 06, 2015
Cornea Cold
K151061 · LYX
Eurobio
Ophthalmic · 108d
Cleared Jul 14, 2015
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green,...
K142398 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 321d
Cleared Jul 10, 2015
IOLMaster700
K143275 · HJO
Carl Zeiss Meditec, Inc.
Ophthalmic · 238d
Cleared Jul 10, 2015
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear,...
K150590 · LPL
Contamac, Ltd.
Ophthalmic · 123d
Cleared Jun 30, 2015
COMPASS
K150320 · MYC
Centervue S.P.A.
Ophthalmic · 141d
Cleared Jun 25, 2015
Ophthalmed Bending Laser Probes
K142830 · HQF
Ophthalmed, LLC
Ophthalmic · 268d
Cleared Jun 24, 2015
VICTUS Femtosecond Laser Platform
K151161 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 54d
Cleared Jun 22, 2015
VISCO SOFT CONTACT LENS
K141348 · LPL
Visco Vision, Inc.
Ophthalmic · 396d
Not Cleared Jun 18, 2015
BRAINPORT V100 DEVICE
DEN130039 · PIC
Wicab, Inc.
Ophthalmic · 680d
Cleared Jun 15, 2015
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for...
K150630 · MVN
Yung Sheng Optical Co., Ltd.
Ophthalmic · 96d
Cleared Jun 01, 2015
VX120 Ophthalmic Diagnostic Device
K143086 · HKX
Luneau Sas
Ophthalmic · 217d
Cleared May 29, 2015
SP-1PSpecular Microscope
K142417 · NQE
Topcon Corporation
Ophthalmic · 274d