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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    CAPENERGY - C100, C200, C300, C400, C50

    K Number: K191202 · Decision Feb 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    281

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    Basic Information

    Device Name
    CAPENERGY - C100, C200, C300, C400, C50
    K Number
    K191202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Capenergy Medical S.L.
    Date Received
    May 6, 2019
    Decision Date
    February 11, 2020
    Product Code
    PBX
    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

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    Other Clearances by Capenergy Medical S.L.

    K Number Device Name
    K222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500