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510(k) Data Aggregation

    K Number
    K192331
    Device Name
    LaseMD LEO Laser System
    Manufacturer
    Lutronic Global
    Date Cleared
    2019-11-12

    (77 days)

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

    Lutronic Global

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LaseMD LEO Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles).
    Device Description
    The LaseMD LEO Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. The LaseMD LEO Laser System is equipped with a 658 nm aiming beam.
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