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
457–480 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared CT Jun 08, 2018
Avanti
K180660 · OBO
Optovue, Inc.
Ophthalmic · 86d
Cleared Jun 08, 2018
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
K180985 · LPL
Supervision Optimax Sdn Bhd
Ophthalmic · 56d
Cleared Jun 08, 2018
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58...
K180988 · HQD
Acuity Polymers, Inc.
Ophthalmic · 53d
Cleared Jun 07, 2018
AT 030
K180839 · HKY
Carl Zeiss Meditec, AG
Ophthalmic · 69d
Cleared May 30, 2018
Retia 2
K180293 · MYC
Centervue S.P.A.
Ophthalmic · 118d
Cleared May 25, 2018
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
K180402 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 100d
Not Cleared May 17, 2018
TrueTear Intranasal Tear Neurostimulator
DEN170086 · QBR
Allergan
Ophthalmic · 206d
Cleared May 16, 2018
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
K180819 · LPL
Menicon Co, Ltd.
Ophthalmic · 48d
Cleared Apr 27, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K180669 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 44d
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 CT 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