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510(k) Data Aggregation

    K Number
    K134017
    Device Name
    GIGALASER
    Manufacturer
    POWERMEDIC APS
    Date Cleared
    2014-05-02

    (123 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    POWERMEDIC APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GIGALaser 1801 is intended to emit energy in the visible and near infraced spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of min and stiffhess, minor arthritis pain, or muscle spassn; the temporary increase in local blood circulation; and for the temporary relaxation of muscles.
    Device Description
    The GIGALaser 1801 is a non-invasive, low level therapeutic laser lamp. The control unit contains the power supply and the user interface panel. The IR laser lamp is placed on a folding arm which is attached to the base unit. The interface panel consists of three buttons for 'STOP', 'START' AND 'PAUSE' and there are 6 buttons for the 6 different pre-programmed treatment programs labeled 1 - 6. The buttons light up when selected. A LED segment tells the user the time the treatment has run. The GIGALaser 1801 is also equipped with a main key power switch and an emergency stop. The GigaLaser is a medical device, which is delivered with a user and therapy manual and a complete labeling for the user.
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    K Number
    K070516
    Device Name
    POWERLASER
    Manufacturer
    POWERMEDIC APS
    Date Cleared
    2007-07-02

    (130 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    POWERMEDIC APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.
    Device Description
    The PowerLaser is a hand-held, battery operated, non-invasive, low level infrared therapeutic laser lamp. A separate battery charger can recharge the battery when it is removed from the PowerLaser. PowerLaser is a medical device, which is delivered packed with battery charger and complete labeling for the user.
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