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510(k) Data Aggregation

    K Number
    K070442
    Device Name
    POWERLED SURGICAL LIGHT SYSTEM
    Manufacturer
    MAQUET S.A.
    Date Cleared
    2007-03-16

    (29 days)

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

    MAQUET S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAQUET POWERLED™ Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient. An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination. An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's: head, and to compensate for loss of illumination due to an obstacle in front of the supola.
    Device Description
    The POWERLED™ Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principles as the ALM X'TEN® (X10) Surgical Light Systems. The POWERLED™ Surgical Light provides a broadened set of features and options that include LEDs as the main light source as well as an added optional automatic head recognition system feature as a result of this redesign effort.
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