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510(k) Data Aggregation

    K Number
    K160952
    Device Name
    Alma Diode Tabletop Laser
    Manufacturer
    ALMA LTD
    Date Cleared
    2016-05-05

    (30 days)

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

    ALMA LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures. Indications for Use laser assisted lipolysis. The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules: The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins. The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis. The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for
    Device Description
    The Alma Diode Tabletop Laser is comprised of the following major components: - The main console unit 1. - 2. Pull-back - 3. Footswitch - Accessories 4.
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