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510(k) Data Aggregation

    K Number
    K172639
    Device Name
    PALLAS 308/311 Solid-State UV Laser System
    Manufacturer
    Laseroptek Co.Ltd
    Date Cleared
    2017-11-03

    (63 days)

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

    Laseroptek Co.Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
    Device Description
    Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.
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