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
673–696 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 15, 2015
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft...
K150293 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 68d
Cleared Apr 09, 2015
LIOLI IOL DELIVERY SYSTEM
K142056 · MSS
Ast Products, Inc.
Ophthalmic · 254d
Cleared Mar 20, 2015
LENSAR Laser System - fs 3D
K143010 · OOE
Lensar, Inc.
Ophthalmic · 151d
Cleared Mar 20, 2015
myVision Track Model 005
K143211 · HOQ
Vital Art and Science Incorporated
Ophthalmic · 130d
Cleared Mar 13, 2015
EVA,anterior machine, EVA, combined machine, EVA combined machine with...
K142877 · HQC
Dutch Ophthalmic Research Center...
Ophthalmic · 163d
Cleared Mar 12, 2015
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
K142766 · LPL
INTEROJO, Inc.
Ophthalmic · 168d
Cleared Mar 04, 2015
OCT-Camera
K142953 · HLI
Optomedical Technologies GmbH
Ophthalmic · 145d
Cleared Feb 27, 2015
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
K141922 · NFJ
Intelligent Retinal Imaging Systems, LLC
Ophthalmic · 226d
Cleared Feb 27, 2015
LIGHTMED TRUSCAN 577
K142172 · HQF
Lightmed Corp.
Ophthalmic · 204d
Cleared Feb 24, 2015
Synergetics PHOTON EX
K143123 · MPA
Synergetics
Ophthalmic · 116d
Cleared Feb 20, 2015
FIBERION OPHTHALMIC ENDOLASER PROBE
K133019 · HQF
Emtron Elektronik VE Mekanik Sanayi...
Ophthalmic · 512d
Cleared Feb 20, 2015
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K143431 · LPL
I-Codi Co., Ltd.
Ophthalmic · 81d
Cleared Feb 13, 2015
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic)...
K143632 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 53d
Cleared Jan 29, 2015
HEINE SIGMA 250 & HEINE SIGMA 250 M2
K142837 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Jan 26, 2015
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
K142284 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 161d
Cleared Jan 16, 2015
VICTUS FEMTOSECOND LASER PLATFORM
K141379 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 234d
Cleared Jan 16, 2015
P200DTx
K142897 · MYC
Optos Plc.
Ophthalmic · 105d
Cleared Jan 16, 2015
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
K143190 · MVN
Yung Sheng Optical Co., Ltd.
Ophthalmic · 72d
Cleared Jan 12, 2015
Intelliwave4
K142641 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 117d
Cleared Jan 12, 2015
DacryoCATH
K142914 · OKS
Armadillo Biomedical, LLC
Ophthalmic · 97d
Cleared Dec 18, 2014
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
K143307 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 30d
Cleared Dec 16, 2014
Sensor Medical Family of Vitrectomy Lenses and Products
K142715 · HJK
Sensor Medical Technology, LLC
Ophthalmic · 85d
Cleared Dec 16, 2014
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for...
K143052 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 54d
Cleared Dec 12, 2014
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K142384 · LPL
Qualimed Srl
Ophthalmic · 108d