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510(k) Data Aggregation

    K Number
    K093386
    Device Name
    CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
    Manufacturer
    BFW, INC
    Date Cleared
    2010-01-28

    (90 days)

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

    BFW, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products. The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.
    Device Description
    The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems. Its' intended function and use is to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products. The XtremeBeam Fiber Optic Headlight is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures. It is constructed of a durable plastic housing, lenses, spot size adjustment, and positioning bar. It utilizes a proprietary fiber optic cable, the distal end of which will fit an ACMI port. The luminaire optics consist of optic lenses, a mirror, and an iris.
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