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510(k) Data Aggregation

    K Number
    K243716
    Device Name
    Zionic Pro Max (Radiofrequency)
    Manufacturer
    TermoSalud S.L.
    Date Cleared
    2025-05-28

    (177 days)

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

    TermoSalud S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The Zionic Pro Max with Radiofrequency is a non-invasive topical heating device that produces RF energy to warm subcutaneous tissue the therapeutic temperature of 40-45°C. The device includes two different type of RF handpieces, resistive and capacitive, which are connected to a console and software-powered user interface. The Zionic Pro Max adds a new capacitive handpiece and user interface to a previously cleared generation of the device.
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