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510(k) Data Aggregation

    K Number
    K983984
    Device Name
    COOLTOUCH V ND:YAG
    Manufacturer
    LASER AESTHETICS, INC.
    Date Cleared
    1999-06-07

    (210 days)

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

    LASER AESTHETICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laser Aesthetics COOLTOUCH "V" Nd:YAG laser is indicated for use in surgical procedures for the coagulation and hemostasis of vascular lesions and soft tissue.
    Device Description
    The Laser Aesthetics COOLTOUCH "V" Nd:YAG Surgical Laser is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics and the handpiece.
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