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    K Number
    K022384
    Device Name
    XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
    Manufacturer
    ISOLUX AMERICA
    Date Cleared
    2002-10-18

    (88 days)

    Product Code
    HET, HIE
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISOLUX AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 1300 XSBP - 300 WATT XENON Illuminator is intended for use as a high intensity light to be used with fiberoptic cables. Applications include endoscopes, surgical headlights and other tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.
    Device Description
    Isolux America has engineered the 1300 XSBP - 300 Watt Xenon to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon lamp with focusing optics, a variable attenuator, a turret selector for four standard fiber optic cable connectors and a forced air cooling system consisting of two fans.
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    K Number
    K991572
    Device Name
    ISOLUX SURGICAL HEADLIGHT
    Manufacturer
    ISOLUX AMERICA
    Date Cleared
    1999-07-08

    (64 days)

    Product Code
    FST
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISOLUX AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISOLUX America's Surgical Headlight is indicated for illumination purposes from an illuminator to a headlight to aid in providing illumination to body cavities during examinations or surgical procedures.
    Device Description
    Not Found
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    K Number
    K991208
    Device Name
    ENDOSCOPIC FIBEROPTIC CABLE
    Manufacturer
    ISOLUX AMERICA
    Date Cleared
    1999-06-23

    (75 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISOLUX AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISOLUX America's fiber optic cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
    Device Description
    Fiberoptic Cable
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