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510(k) Data Aggregation

    K Number
    K163526
    Device Name
    Bilicocoon™ Phototherapy System
    Manufacturer
    NEOMEDLIGHT
    Date Cleared
    2017-10-06

    (294 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMEDLIGHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.
    Device Description
    The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed. The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin. The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.
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