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510(k) Data Aggregation

    K Number
    K073300
    Device Name
    MILESMAN PREMIUM
    Manufacturer
    MILESMAN S.L.
    Date Cleared
    2007-12-04

    (11 days)

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

    MILESMAN S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Milesman Premium Pulsed Diode Array Laser System is intended for use in general and plastic surgery and dermatology procedures for the treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions and treatment for pseudofolliculitis barbae. The Milesman Premium is also used for removal of unwanted hair, permanent hair reduction and the treatment of benign pigmented lesions and leg veins in all skin types (Fitzpatrick I-VI), including tanned skin.
    Device Description
    The Milseman Premium Pulsed Diode Array Laser System delivers pulsed laser light at 800 nm wavelength. The device consists of three interconnected sections: the system console, the handle hose (umbilical cord) to the handpiece, and the handpiece. The laser pulsed energy is delivered through the handpiece. A user is able to select specific laser parameters from the touch screen on top of the console.
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