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510(k) Data Aggregation

    K Number
    K200736
    Device Name
    Stardust Med
    Date Cleared
    2020-06-26

    (95 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. Group S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery. STARDUST MED is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime
    Device Description
    STARDUST MED is a laser emitting device that is operated with handpiece in contact with the skin. STARSDUST MED comprises a main console unit and a handpiece that is triggered by means of footswitch or a finger switch. A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface. The main console can be connected to the following handpiece: - -808 nm Laser diode.
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