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
457–480 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 25, 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100...
K180616 · HQD
Contamac, Ltd.
Ophthalmic · 48d
Cleared Apr 20, 2018
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
K180322 · LPL
Visco Vision, Inc.
Ophthalmic · 74d
Cleared Apr 13, 2018
VisuMax Femtosecond Laser
K173371 · HNO
Carl Zeiss Meditec, Inc.
Ophthalmic · 168d
Not Cleared Apr 11, 2018
IDx-DR
DEN180001 · PIB
Idx, LLC
Ophthalmic · 89d
Cleared Apr 10, 2018
ACUVUE OASYS (senofilcon A) with Photochromic Additive
K180299 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 67d
Cleared Apr 10, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K180398 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 56d
Cleared Apr 05, 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K180378 · HKI
Optomed OY
Ophthalmic · 52d
Cleared Apr 03, 2018
OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua...
K173958 · LPL
Visco Vision, Inc.
Ophthalmic · 96d
Cleared Mar 27, 2018
LenSx Laser System
K173660 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 118d
Cleared Mar 27, 2018
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance...
K180319 · MRC
Bausch and Lomb, Incorporated
Ophthalmic · 50d
Cleared Mar 16, 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible...
K180172 · HQD
Paragon Vision Sciences
Ophthalmic · 53d
Cleared Mar 16, 2018
Frigitronics adapter
K180195 · HRN
Phakos
Ophthalmic · 51d
Cleared Mar 14, 2018
Specular Microscope CEM-530
K173980 · NQE
Nidek Co., Ltd.
Ophthalmic · 75d
Cleared Mar 09, 2018
CATS Tonometer Prism
K173904 · HKY
Cats Tonometer, LLC
Ophthalmic · 77d
Cleared Mar 02, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K173346 · OOE
Lensar, Inc.
Ophthalmic · 128d
Cleared Feb 28, 2018
P200TE
K173707 · OBO
Optos Plc.
Ophthalmic · 86d
Cleared Feb 23, 2018
Ophthalmic Software Platform RX
K173689 · NFJ
Canon Inc. -Medical Equipment Group
Ophthalmic · 84d
Cleared Feb 22, 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · LPL
Menicon Co, Ltd.
Ophthalmic · 51d
Cleared Jan 19, 2018
EM-4000 Specular Microscope
K171313 · NQE
Tomey Corporation
Ophthalmic · 260d
Cleared Jan 19, 2018
DRI OCT Triton
K173119 · OBO
Topcon Corporation
Ophthalmic · 112d
Cleared Dec 26, 2017
iLux Instrument, iLux Disposable
K172645 · ORZ
Tear Film Innovations, Inc.
Ophthalmic · 116d
Cleared Dec 21, 2017
SLM-1ER, SLM-2ER, SLM-3ER
K171877 · HJO
Chongqing Kanghua Ruiming S&T Co., Ltd.
Ophthalmic · 181d
Cleared Dec 21, 2017
OMNI Surgical System
K173332 · MRH
Sight Sciences, Inc.
Ophthalmic · 59d
Cleared Dec 15, 2017
pioli IOL Delivery System
K172228 · MSS
Ast Products, Inc.
Ophthalmic · 143d