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    K Number
    K123293
    Device Name
    PASTELLE Q-SWITCHED ND: YAG LASER
    Manufacturer
    WON TECHNOLOGY CO., LTD.
    Date Cleared
    2013-04-11

    (171 days)

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

    WON TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
    Device Description
    The WON Technology's Pastelle Q-Switched Nd:YAG Laser uses a Nd: YAG material to generate the Qswitching laser. The device is comprised of a main body, articulated arm, foot switch and ancillary accessories. This device is designed to provide laser energy for use in a variety of dermatological procedures. The 532nm and 1064nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very broad laser pulses (6-20ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
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