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510(k) Data Aggregation

    K Number
    K093792
    Device Name
    LED LIGHT SOURCE
    Manufacturer
    SUNOPTIC TECHNOLOGIES, LLC
    Date Cleared
    2010-03-18

    (98 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNOPTIC TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.
    Device Description
    LED Light Source (LLS-050 LED Illuminator)
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