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510(k) Data Aggregation

    K Number
    K133425
    Device Name
    SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC.
    Date Cleared
    2013-12-05

    (27 days)

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

    ENGINEERED MEDICAL SOLUTIONS CO. LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.
    Device Description
    The Scintillant Dual Tip Light is a sterile, single-use device designed to provide surgeons with localized brilliant white illumination of the surgical site. Utilizing an internal battery, the device is designed to stay operational for up to three hours of continuous use. Dual light tips in combination with flexible leads containing memory wire allows for the surgeon to direct light from multiple locations optimizing the illumination provided by the device and allowing for increased visibility within the surgical site.
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    K Number
    K071180
    Device Name
    SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC
    Date Cleared
    2007-06-20

    (51 days)

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

    ENGINEERED MEDICAL SOLUTIONS CO. LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scintillant light is intended to provide localized illumination of surgical sites. The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.
    Device Description
    The Scintillant Surgical Light is an untethered, self-contained medical lighting device that allows illumination inside the surgical field. The light can be hand-held and is provided with accessories which allow it to be attached to almost any surgical tool or instrument. The light is provided sterile and is battery powered. The light consists of light-emitting diode (LED) mounted on the end of a flexible wand. A single button turns the light on and off. A battery and circuit board are contained in the device handle.
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