BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    PolyDev Soft Contact Lenses

    K Number: K160977 · Decision Jul 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    3
    Review Days
    97

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    Basic Information

    Device Name
    PolyDev Soft Contact Lenses
    K Number
    K160977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polydev , Ltd.
    Date Received
    April 7, 2016
    Decision Date
    July 13, 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 Polydev , Ltd.

    K Number Device Name
    K171157 PolyDev Soft Contact Lenses
    K161931 Toricolors (hioxifilcon D) Soft Contact Lenses