BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AVT NATURASOFT

    K Number: K121324 · Decision Aug 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    AVT NATURASOFT
    K Number
    K121324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Vision Technologies
    Date Received
    May 2, 2012
    Decision Date
    August 23, 2012
    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 Advanced Vision Technologies

    K Number Device Name
    K152724 EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES