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510(k) Data Aggregation

    K Number
    K130283
    Device Name
    EVRF SYSTEM
    Manufacturer
    F CARE SYSTEMS NV
    Date Cleared
    2013-03-07

    (30 days)

    Product Code
    ONQ
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    F CARE SYSTEMS NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
    Device Description
    The EVRF has 2 major parts: 1) the generator and 2) the needle. The generator creates the impulse. The impulse can be set at between in 0.1 second increments. The combination of these two settings means that highly accurate doses of energy can be delivered. The system utilizes a current of 4MHz .The power and impulse values are accurately maintained by a microprocessor and displayed on a LCD screen. The values can be digitally adjusted. The ultra-fine needle (Product Code KCW) has a diameter of 0.075 mm allowing for accurate operation and is protected by a specific isolating sheath. The vessel is thermocoagulated without damaging the epidermis and surrounding tissue. Needles are nickel. In case of a nickel allergy, gold needles are also available. The needles are disposable and can be used for a complete session. The combination of the generator and insulated needle allows for a very precise amount of energy to be delivered to exactly the right place.
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