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510(k) Data Aggregation

    K Number
    K110550
    Device Name
    BRIGHT EMBRACE MODEL SBL60
    Manufacturer
    PHYSICIAN ENGINEERED PRODUCTS, INC.
    Date Cleared
    2012-02-03

    (343 days)

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

    PHYSICIAN ENGINEERED PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bright Embrace Model SBL60 phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath and around the neonate. The Bright Embrace can be used in a clinical setting or in the home.
    Device Description
    The Bright Embrace Model SBL60 is a single-patient, portable phototherapy light that was specifically designed to incorporate these features: - 1) high intensity blue light over a large body surface area as recommended by the American Academy of Pediatrics (AAP); - 2) the ability to hold the newborn during treatment; - 3) single patient use to minimize cross-contamination in hospitals and to facilitate home care logistics: The Bright Embrace Model SBL60 delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia, also called newborn jaundice. The Bright Embrace Model SBL60 is designed to provide phototherapy treatment from a wrap-around design that provides light from underneath, the sides and partially the front of the newborn to achieve a large body surface area of treatment. The blue LEDs used in the Bright Embrace Model SBL60 emit light in the range of 430-510nm (peak wavelength 480nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the desirable degradation of bilirubin under the exposed skin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the newborn. As with most phototherapy devices, protective eye shades or goggles must be used to protect the newborn's eyes from excessive light exposure.
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    K Number
    K093618
    Device Name
    BILI-MIRROR MODEL BLM-1
    Manufacturer
    PHYSICIAN ENGINEERED PRODUCTS, INC.
    Date Cleared
    2010-04-23

    (151 days)

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

    PHYSICIAN ENGINEERED PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bili-Mirrors are intended to attach to overhead phototherapy light fixtures to limit the scattering of light.
    Device Description
    The Bili-Mirror is simply a 10"-high by 54"-wide metalized, 3 mil polyester film that removably attaches (like a skirt) to the lower edge of overhead phototherapy devices. It serves three useful purposes. First, the 3 ohm metalized film serves as a mirror to reflect phototherapy light from the overhead device back onto baby - thereby increasing the phototherapy dose by up to 70% depending upon the distance of light-to-baby. Second, the Bili-Mirror decreases by over 95% the bright "scatter" from the phototherapy device from reaching the eyes of caregivers. Third, unlike the predicate device, the 3 ohm metalizing of the Bill-Mirror provides for a seethrough mirror that allows good visibility of baby as viewed through the Bili-Mirror.
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    K Number
    K974830
    Device Name
    ULTRA BILI LIGHT
    Manufacturer
    PHYSICIAN ENGINEERED PRODUCTS, INC.
    Date Cleared
    1998-05-20

    (147 days)

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

    PHYSICIAN ENGINEERED PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the portable Ultra Bili Light model 2000 is to provide Home Phototherapy treaturent for Neonatal Hyperbilirubinemia.
    Device Description
    Ultra Bili Light
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