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510(k) Data Aggregation

    K Number
    K021149
    Device Name
    AURORA DS
    Manufacturer
    SYNERON MEDICAL LTD.
    Date Cleared
    2002-07-09

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K991935,K954031,K000944
    Predicate For
    K024064,K031489,K031988
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Aurora DS is intended for use in dermatology for non invasive hair removal.
    The Aurora DS is indicated for non-invasive hair removal.

    Device Description

    The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.

    AI/ML Overview

    The provided text includes a 510(k) summary for the Aurora DS device. However, it does not contain any information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, primarily for non-invasive hair removal.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as that information is not present in the provided text.

    The closest information available is the intended use: "The Aurora DS is intended for use in dermatology for non invasive hair removal." This implies that the device's functional performance related to hair removal has been deemed acceptable for its regulatory submission, but no specific metrics or study details are provided.

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