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510(k) Data Aggregation

    K Number
    K083008
    Device Name
    COOLSKIN
    Manufacturer
    ELBIO CO., LTD
    Date Cleared
    2009-06-10

    (245 days)

    Product Code
    ILO
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELBIO CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.
    Device Description
    COOLSKIN is a 14" by 16" by 2 ¾ ft, 66 lb thermo-cooling mobile device that applies controlled cooling in the range of 3 degrees F to 50 degrees F (-16 degrees C to 10 degrees C) at skin surface in order to decrease skin temperature via a probe which is in direct contact with the skin surface. The device operates by semiconductor using Peltier principle. While the proximal side (towards the skin surface) gets cold, the distal side gets hot. The hot side is cooled by a water cooling system, which runs to the probe tip via a water circulating tube, and cools it. The warm/hot water is channeled away to the main unit where it is cooled via a fan. The probe is available in small and large versions.
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