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510(k) Data Aggregation

    K Number
    K992914
    Device Name
    EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000
    Manufacturer
    ACCULASE, INC.
    Date Cleared
    2000-01-27

    (150 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCULASE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UVB Phototherapy for Psoriasis
    Device Description
    The Excimer Laser Phototherapy System, AL7000 is a complete self-contained compact laser light source, which utilizes a XeCl gas mixture to generate ultraviolet light at wavelength of 308 nm wavelength. The laser system consists of a keypad and display, a fiberoptic delivery system, a footswitch, and a handpiece. The laser is enclosed in a protective interlocked housing.
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