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    K Number
    K063621
    Device Name
    3 SERIES PHOTOTHERAPY CABINET
    Manufacturer
    DAAVLIN CO.
    Date Cleared
    2007-01-17

    (43 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAAVLIN CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3 Series PC & SP, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
    Device Description
    The 3 Series PC & SP phototherapy cabinet is a microprocessor controlled full body fluorescent ultraviolet light source, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). It is intended for use by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The 3 Series delivers full body phototherapy, whereby fluorescent tubes, which surround the patient, deliver the specified dose of UVA and/or UVB light.
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