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510(k) Data Aggregation

    K Number
    K100702
    Device Name
    STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
    Date Cleared
    2010-07-20

    (130 days)

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

    HUOT INSTRUMENTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The StarTrol LED Lighting system is designed to provide a visible illumination of the examination /surgical field of the patient during surgical and non-surgical procedures.
    Device Description
    The StarTrol LED Lighting System is a Class II medical device that provides an illumination field for general examination and minor surgery. The lighting system utilizes LED's for illumination and is powered from standard AC voltage sources. The head design is comprised of multiple LED's (Light Emitting Diodes). The LED head is mounted such that it can be moved and oriented by the operator to place the illumination field on the subject by means of a removable handle (sterile, single use handle covers are available). The light head is balanced with a counterweight to provide flexibility and exact placement without the drifting of the light head. Maneyverability of the light head requires minimal force by the clinician to quickly and easily place it in the desired position. The intensity of illumination is variable.
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