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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens

    K Number: K181349 · Decision Sep 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    11
    Review Days
    121

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    Basic Information

    Device Name
    Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens
    K Number
    K181349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visco Vision, Inc.
    Date Received
    May 21, 2018
    Decision Date
    September 19, 2018
    Product Code
    LPL
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by Visco Vision, Inc.

    K Number Device Name
    K200618 HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
    K201080 Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
    K191397 OxySoft (olifilcon C) silicone hydrogel soft contact lens
    K183670 Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens
    K180322 Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
    K173958 OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
    K171447 OxyPure Color Silicone Hydrogel Soft Contact Lenses
    K160245 Visco (olifilcon A) soft contact lens
    K160344 Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
    K141348 VISCO SOFT CONTACT LENS
    Search all 11 clearances from Visco Vision, Inc. →