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510(k) Data Aggregation

    K Number
    K212472
    Device Name
    AgeJet
    Manufacturer
    Date Cleared
    2022-07-07

    (335 days)

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

    Triworks Group SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Agelet system is an electrosurgical device and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The AgeJet system is an electro-surgical device intended for use in dermatological applications in hospital and clinics. The AgeJet system comprises of the following: AgeJet Generator, Footswitch, Handpiece/Cable Assembly, Handpiece holder, Procedure Pack, Nitrogen Gas Cylinder & Pressure regulator, and Cylinder Holder Plate Kit.
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    K Number
    K192621
    Device Name
    Medical RF
    Manufacturer
    Date Cleared
    2020-11-06

    (410 days)

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

    Triworks Group SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types
    Device Description
    The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types. The mechanism of action of the Subject Device involves the delivery of thermal energy to the subcutaneous tissue and the deep dermis. The Device utilizes the electromagnetic waves originated from two poles: a single electrode on the handpiece that contacts the skin and a grounding reference plate (monopolar RF), or two electrodes of the handpiece placed over the treatment area (bipolar RF). Medical RF is equipped with three types of handpieces: Two monopolar handpieces (small and medium) and one bipolar handpiece; all of them contain a sensor temperature used by the DTC (Derma Temperature Control) technology. The DTC is an innovative system that instantly detects the temperature of the skin and regulates the power emissions to maintain (at the same value) the transferred temperature of RF during the treatment. The DTC system allows the operator to know the real-time temperature of the skin surface, there is no further need to manually regulate the power according to the temperature changes during the treatment session. DTC technology ensures the safety and effective functioning of the Subject Device. The user always knows the real-time temperature on the skin during the treatment and does not have to manually change the power emissions in relation to the patient's perception of heat, thereby improving the efficacy of the treatment. The Subject Device is recommended to be used by trained and qualified personnel only and includes a dedicated software (interface RS-232), installed by the manufacturer in the device's memory.
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