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510(k) Data Aggregation

    K Number
    K031988
    Device Name
    AURORA DS
    Manufacturer
    SYNERON MEDICAL LTD.
    Date Cleared
    2003-08-01

    (35 days)

    Product Code
    GEX,GEI
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K021149
    Predicate For
    K033586,K050397
    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 is a 510(k) summary for the Syneron Medical Ltd. AURORA DS device. It outlines the company, device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

    The document primarily focuses on establishing substantial equivalence for a modification (an increase in RF energy output) to an already cleared device. It explains that the modification does not affect intended use or fundamental scientific technology and raises no new safety or effectiveness issues.

    Therefore, I cannot provide the requested table and study details as they are not present in the given input.

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