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510(k) Data Aggregation

    K Number
    K083629
    Device Name
    SMOOTHSHAPES
    Manufacturer
    ELEME MEDICAL, INC.
    Date Cleared
    2009-02-19

    (73 days)

    Product Code
    NUV
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K053611,K061603,K071872
    Predicate For
    K100230
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Elemé Medical SmoothShapes® system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

    Device Description

    The SmoothShapes® System featuring Photomology® technology is designed to offer an innovative way to safely and effectively treat cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to reduce the appearance of cellulite.

    AI/ML Overview

    The provided text is a 510(k) summary for the Elemé Medical SmoothShapes® System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, study details, or performance data.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or specific study types like MRMC or standalone performance. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical study demonstrating meeting specific performance criteria.

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