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510(k) Data Aggregation

    K Number
    K251334
    Device Name
    NEW DOUBLO 2.0
    Manufacturer
    Date Cleared
    2025-09-29

    (152 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NEW DOUBLO 2.0 with RM and RM(B) handpiece is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
    The NEW DOUBLO 2.0 with PS handpiece is intended for the removal and destruction of skin lesions and coagulation of tissue.

    Device Description

    This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, three handpieces, foot switch, LCD touchscreen and power cable.

    The NEW DOUBLO 2.0 has three handpieces:

    The device is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis with RM and RM(B) handpieces and the removal and destruction of skin lesions and coagulation of tissue with PS handpiece.

    The device is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.

    RF uses electromagnetic wave frequencies to generate an electric field within tissue to cause heating. The amount of energy delivered to tissue is proportional to the current, time, and resistance within the tissue, also known as impedance. Tissue impedance is the main variable in the amount of heat delivered by the generated electric current.

    High frequency amplification is performed and it is transmitted to the handpiece. The corresponding output is controlled through the Foot Switch and Hand Switches, and when the Foot Switch and Hand Switches are pressed, each handpiece irradiates the transmitted high-frequency energy to the skin.

    AI/ML Overview

    N/A

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