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510(k) Data Aggregation

    K Number
    K990043
    Device Name
    SMOOTHLASE ALEXANDRITE LASER SYSTEM
    Manufacturer
    LEISEGANG MEDICAL, INC.
    Date Cleared
    1999-02-11

    (36 days)

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

    LEISEGANG MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmoothLASE TM Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE TM Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.
    Device Description
    The SmoothLASE TM Alexandrite Laser System is a medical device which is capable of emitting an invisible treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. In addition to the standard pulse width of nominally 1 Msec at 1Hz, the SmoothLASE TM Alexandrite Laser System will operate up to 3 Hz. Additionally, a single pulse is modulated to provide 6 x 1 Msec pulses at 1.3 Hz.
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