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510(k) Data Aggregation

    K Number
    K011693
    Device Name
    TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
    Date Cleared
    2001-06-13

    (13 days)

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

    TRUMPF MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.
    Device Description
    Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates. An optional laser pilot is available on the Models 501, 701 and 1001. The laser pilot exactly marks the center of the light field. This makes it easier for the user to focus the light field with precision even if the operating area is very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of < 1 mW. The Model 1001 is also equipped with an anti-drift system. As soon as the light comes to a standstill, it will be fixed in position by built-in magnetic brakes. The brakes are automatically released whenever the handrail surrounding the light (or central handle) is touched.
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