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510(k) Data Aggregation

    K Number
    K171094
    Device Name
    Thermi Reusable Non-invasive RF Electrode
    Manufacturer
    ThermGen, L.L.C
    Date Cleared
    2017-05-08

    (26 days)

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

    ThermGen, L.L.C

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermi Reusable Non-Invasive RF Electrodes used with the Thermi RF Generator System are indicated: - for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
    Device Description
    The Thermi Reusable Non-Invasive RF Electrode is a transcutaneous thermal/coagulation electrode designed to provide finely-controlled radiofrequency (RF) energy in combination with Thermi RF Generator. They are not intended to function with non-Thermi branded products. The electrode connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit. The Electrode delivers the RF signal from the generator to the electrode active tip. From the active tip, the RF signal triggers the tissue molecules to vibrate resulting in the formation of heat.
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