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510(k) Data Aggregation

    K Number
    K210693
    Device Name
    PLEXR PLUS
    Manufacturer
    Date Cleared
    2022-03-22

    (379 days)

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

    GMV S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Plexr Plus is used in the removal and destruction of skin lesions and coagulation of tissue.
    Device Description
    Plexr Plus utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by high frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A stainless steel straight disposable active sterilized tip is not available with the system and is not supplied by the company. Three cordless handpieces with three fixed powers are charged in a docking/charging station prior to use.
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