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510(k) Data Aggregation

    K Number
    K232992
    Device Name
    10THERMA
    Manufacturer
    Date Cleared
    2023-12-20

    (89 days)

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

    Tentech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    10THERMA indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat. The 10THERMA is comprised of a main body with a touch LCD monitor, a handpiece, nonsterile mono-polar electrodes (handpiece tips), return pad connector, coupling fluid, cooling gas (cryogen), a power cable, and a foot switch. Among the consisting items, the mono-polar electrodes, return pads, and coupling fluid are single-use and disposable.
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