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    K Number
    DEN090012
    Device Name
    VIRULITE COLD SORE MACHINE
    Manufacturer
    VIRULITE LLC
    Date Cleared
    2012-10-18

    (1206 days)

    Product Code
    OKJ
    Regulation Number
    878.4860
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRULITE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViruLite Cold Sore Machine is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.
    Device Description
    The ViruLite is a solid state opto-electronic device that emits a controlled quantity of 1072nm +/- 12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The power source is a standard alkaline 9V battery. which is replaceable. The tip of the device that contacts the patient is made out of Acrylonitiile Butadiene Stvrene (ABS).
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