LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K024064
    Device Name
    POLARIS DS
    Manufacturer
    SYNERON MEDICAL LTD.
    Date Cleared
    2003-02-10

    (63 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K021149,K013028,K010005,K003993
    Predicate For
    K030186,K041959
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Polaris DS is indicated for non invasive hair removal.

    Device Description

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

    AI/ML Overview

    The provided document is a 510(k) summary for the Syneron Medical Ltd. Polaris DS device, stating its substantial equivalence to predicate devices for non-invasive hair removal. It does not contain information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or comparative effectiveness studies.

    Therefore, I cannot fulfill your request for the detailed information as the document lacks these specifics. The 510(k) summary focuses on demonstrating substantial equivalence to existing devices rather than presenting the detailed results of a performance study with acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1