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    K Number
    K071698
    Device Name
    AURORA LED SERIES SURGICAL LIGHTS
    Manufacturer
    SKYTRON, DIV. THE KMW GROUP, INC.
    Date Cleared
    2007-07-06

    (15 days)

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

    SKYTRON, DIV. THE KMW GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurora LED series surgical light is intended to provide local illumination at the surgical site on the patient's body at Hospitals, Clinics, VA's, Freestanding Surgical centers, Ambulatory/Care Centers and Doctor's offices. The SKYTRON Aurora series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites.
    Device Description
    The Aurora LED series surgical light is suitable for all types of surgical procedures. The Aurora series surgical light is intended to provide local surgical site illumination throughout the patient's body providing a high-intensity, shadow-free "cold" pattern of light. The lights consist of several modules containing LEDs (light emitting diodes) and optical color corrective reflectors. Each light head features independent focus capability allowing the user to adjust the illumination parameters. The light intensity is adjustable between 10% - 100% and a color temperature of 4000K - 4500K creating the infinite capability to adapt to different situations. LEDs offer low heat radiation and increased illumination and are energy saving.
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    K Number
    K021585
    Device Name
    STELLAR SERIES SURGICAL LIGHTS WITH HERMES
    Manufacturer
    SKYTRON, DIV. THE KMW GROUP, INC.
    Date Cleared
    2002-11-13

    (183 days)

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

    SKYTRON, DIV. THE KMW GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC). A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.
    Device Description
    Stellar Series Surgical Lights with Hermes
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    K Number
    K002463
    Device Name
    STELLAR
    Manufacturer
    SKYTRON, DIV. THE KMW GROUP, INC.
    Date Cleared
    2000-11-08

    (90 days)

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

    SKYTRON, DIV. THE KMW GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992090
    Device Name
    MILLENNIUM GOLD
    Manufacturer
    SKYTRON, DIV. THE KMW GROUP, INC.
    Date Cleared
    1999-09-08

    (79 days)

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

    SKYTRON, DIV. THE KMW GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millennium Gold Series Surgical light is intended to be used by medical personnel for the purpose of illuminating surgical sites.
    Device Description
    Not Found
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