BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens

    K Number: K143280 · Decision Apr 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    1
    Review Days
    160

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    Basic Information

    Device Name
    BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
    K Number
    K143280
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brien Holden Vision Pty , Ltd.
    Date Received
    November 14, 2014
    Decision Date
    April 23, 2015
    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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