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510(k) Data Aggregation

    K Number
    K083352
    Device Name
    VEINWAVE, TC3000
    Manufacturer
    NEWLANDS CLINICAL TRIALS LTD
    Date Cleared
    2009-06-12

    (211 days)

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

    NEWLANDS CLINICAL TRIALS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
    Device Description
    The Veinwave/TC3000 system consists of a power generator and a needle through which a controlled dose of radio frequency energy is delivered and is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
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