Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130689
    Device Name
    SYMPHONY RF GENERATOR
    Manufacturer
    THERMIGEN, INC.
    Date Cleared
    2013-11-15

    (247 days)

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

    THERMIGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ThermiGen Symphony RF Generator System and the probes that are used with it are indicated - . for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. - to create lesions in nervous tissue when used in combination with NeuroTherm . (previously Smith&Nephew) thermal/coagulation probes.
    Device Description
    The Symphony RF is a 20 watt electro-thermal radio frequency (RF) generator with integral temperature and impedance feedback. The RF generator is the Smith&Nephew RF Delivery Device, unchanged and in clinical service since Feb 25, 2004 (K033981). The Symphony RF has software changes to allow for two types of electrode/hand-pieces. (1) percutaneous (existing Smith and Nephew thermal/coagulation probes, now owned and manufactured by Neurotherm, Inc.) and (2) the new transcutaneous thermal/coagulation probe, RFE-10-D. The Symphony RF generator has a user interface that displays temperature set point and actual tissue temperature, procedure time, impedance, along with system error and warning codes. The theory of operation of RF devices: The RF generator produces an oscillating electric field in the antenna (handpiece). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermistor intrinsic to the handpiece measures this increase in temperature and in the case of the Symphony RF, a feedback loop maintains a set point temperature in the tissue.
    Ask a Question

    Page 1 of 1