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

    TANDA MINI SKINCARE SYSTEM

    K Number: K124042 · Decision Apr 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    95

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    Basic Information

    Device Name
    TANDA MINI SKINCARE SYSTEM
    K Number
    K124042
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syneron Beauty
    Date Received
    December 28, 2012
    Decision Date
    April 2, 2013
    Product Code
    OLP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLP Over-The-Counter Powered Light Based Laser For Acne

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    Other Clearances by Syneron Beauty

    K Number Device Name
    K122725 TANDA PEARL, ULTRAWYTE, PEARL