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    K Number
    K131226
    Device Name
    NOVAPROBE LED LIGHT SOURCE
    Manufacturer
    NOVAPROBE INCORPORATED
    Date Cleared
    2014-07-24

    (450 days)

    Product Code
    FCW, NTN
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAPROBE INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
    Device Description
    The NOVAPROBE LED LEUKOS 175 is specifically designed to provide the cold light intensity required for modern day Endoscopic procedures. The LED light provides the color temp of 6500 deg K also known as white light. The white light offers unmatched quality for the single chip, three chip and HD cameras. The LED light intensity is controlled digitally. Using LED nullifies any skin burning problems that may occur due to the use of arc lamps. The NovaProbe LED Light source assures that the light passing through the fiber optic cable is a cold light.
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