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510(k) Data Aggregation

    K Number
    K241535
    Device Name
    Vybe RF II
    Manufacturer
    Date Cleared
    2024-09-25

    (118 days)

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

    ShenB Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Microneedle Array Handpiece (1MHz): The Microneedle Array Handpiece with 1 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At power less than 36W, the Microneedle Array Handpiece with 1 MHz functionality is intended for the percutaneous treatment of facial winkles in Skin Types I-V. Microneedle Array Handpiece (2MHz): The Microneedle Array Handpiece with 2 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Microneedle Array handpiece with 2MHz functionality is not intended to treat wrinkles. One Pin Exact Handpiece: The One Pin Exact handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The One Pin Exact Handpiece is not intended to treat wrinkles.
    Device Description
    VYBE RF II is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The device consists of the device console, Microneedle Array Handpiece, One Pin Exact Handpiece, RF plate, Foot Switch, and Power Cord. VYBE RF II is operated through an intuitive user interface (UI) on a 10.4- inch wide touch LCD screen. This product delivers high-frequency energy to the human body through the needle tip cartridge connected to the Microneedle Array Handpiece (1MHz, 2MHz) and One Pin Exact Handpiece (1MHz).
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