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    K Number
    K241157
    Device Name
    Secret MAX Multi-platform RF System
    Manufacturer
    Ilooda Co,.Ltd.
    Date Cleared
    2024-11-21

    (209 days)

    Product Code
    GEI,OUH,PBX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Secret MAX Multi-platform RF System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Secret MAX DEEPLUS MENU and SMARTCURE MENU are intended use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

    The WAVPLUS MENU is intended for the treatment of the following medical condition; using the handpiece for delivery of non-thermal RF energy combined with massage;

    · Relief of minor muscle aches and pain, relief of muscle spasm

    · Temporary improvement of local blood circulation

    · Temporary reduction in the appearance of cellulite

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Secret MAX Multi-platform RF System", outlining its regulatory status and intended use. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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