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    K Number
    K083590
    Device Name
    ISKRA MEDICAL GREEN IRF PRESTIGE
    Manufacturer
    ISKRA MEDICAL, D.O.O.
    Date Cleared
    2009-04-17

    (134 days)

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

    ISKRA MEDICAL, D.O.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
    Device Description
    The Iskra Medical Green IRF Prestige system consists of a user interface, internal electronics controlled by microprocessor, RF generator, 2 treatment handpieces (small and large applicator), and reference electrode. The treatment parameters are selected and controlled via the touch screen.
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