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    K Number
    K133405
    Device Name
    MINNIE
    Manufacturer
    ELETTRONICA VALSERIANA SRL
    Date Cleared
    2014-05-23

    (198 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELETTRONICA VALSERIANA SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Noninvasive treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects.
    Device Description
    MINNIE is a noninvasive radiofrequency device consisting of: • Touch Screen User interface • Programmable Microcontroller • RF Power Module • 4 Treatment Handpieces with following characteristics o Bipolar Handpiece Ø 36mm o Unipolar Handpieces Ø 36mm, 60mm and 80mm MINNIE is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.
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