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510(k) Data Aggregation

    K Number
    K102461
    Device Name
    FRACTORA
    Manufacturer
    INVASIX LTD.
    Date Cleared
    2011-06-02

    (279 days)

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

    INVASIX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.
    Device Description
    The Fractora is composed of a console, hand held applicator, and disposable tip, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins.
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