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    K Number
    K073066
    Device Name
    308 DERMATOLOGICAL EXCIMER SYSTEM
    Manufacturer
    QUANTEL MEDICAL, INC.
    Date Cleared
    2007-12-26

    (57 days)

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

    QUANTEL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.
    Device Description
    The 308 is indicated for dermatological procedures for the treatment of psoriasis and vitiligo. The lamp is a xenon-chloride excimer lamp with a wavelength of 308 nanometers. Its output power is 800 mW ±10% for 2.48 ' ? (16 cm2). It is computer controlled, and displays the treatment parameters.
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