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510(k) Data Aggregation

    K Number
    K202106
    Device Name
    Plasmage System
    Manufacturer
    Brera Medical Inc
    Date Cleared
    2022-04-06

    (616 days)

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

    Brera Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Removal and destruction of skin lesions and the coagulation of skin tissue.
    Device Description
    The Plasmage system is a radiofrequency based professional device exciting an electrical plasma discharge between a metal tip and the patient skin. The discharge deposit thermal energy in the skin and results in removal and destruction of skin lesions and the coagulation of skin tissue. The device is operating in monopolar mode only. The device consists of a console with touch LCD screen and graphic user interface, handpiece with integrated cable, single use electrodes, and foot pedal.
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