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510(k) Data Aggregation

    K Number
    K201738
    Device Name
    SubNovii Advanced Plasma Technology
    Manufacturer
    Cartessa Aesthetics
    Date Cleared
    2020-09-10

    (77 days)

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

    Cartessa Aesthetics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SubNovii is intended for the removal and destruction of skin lesions and coaqulation of tissue.
    Device Description
    The SubNovii Advanced Plasma Technology is a handheld battery powered device that, when activated and placed in close proximity to the skin, generates an ionized electrical arc through the tip of an electrode (Tip) to the skin without the device or the electrode touching the skin. The SubNovii Advanced Plasma Technology consists of the SubNovii handpiece, single use disposable tips and a battery charger.
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