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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

    K Number: K161124 · Decision Aug 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    2
    Review Days
    127

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    Basic Information

    Device Name
    EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
    K Number
    K161124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vision Science Co., Ltd.
    Date Received
    April 21, 2016
    Decision Date
    August 26, 2016
    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 Vision Science Co., Ltd.

    K Number Device Name
    K132714 ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)