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510(k) Data Aggregation

    K Number
    K012545
    Device Name
    ARAMIS DERMATLOGIC LASER
    Manufacturer
    LUMEDICS, LTD.
    Date Cleared
    2001-11-05

    (90 days)

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

    LUMEDICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aramis is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) and the treatment of benign pigmented lesions. The Aramis Dermatologic Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins).
    Device Description
    The Aramis Dermatologic Laser is an Er-glass 1.54 um system. The computer system consists of a laser unit, a cooler, a footswitch, and a 2mm or 4mm hand piece. The 4mm hand piece is gas-cooled to provide actual skin cooling. Laser parameters and other system features are controlled from the touch-buttons on top of the laser unit, which provides an interface to the system computer.
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