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510(k) Data Aggregation

    K Number
    K132016
    Device Name
    LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
    Date Cleared
    2014-06-02

    (336 days)

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

    TEXAS APPLIED BIOMEDICAL SERVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
    Device Description
    Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are laser therapy devices for applications suitable to be used in an ambulatory setting and under the care of a licensed healthcare provider. In particular the device works by providing infrared energy to elevate tissue temperature. The Lumix 3 series laser therapy heat lamp heat devices deliver visible and invisible laser light at the wavelength of 910 nm (pulsed infrared), 808nm (continuous and interrupted infrared) and 650nm (continuous red visible). The pulsed laser sources used are of diodic type for pulsed working mode; the continuous laser sources used are of diodic type for continuous and frequenced working mode. The laser light beam produced by the diode is carried to the focusing lens optic fibers with very low attenuation and high mechanical strength. The laser light, produced by the different sources, is emitted in a single bright beam, which at the optical unit output has a diameter equal to at 20mm. The flexible arm can be oriented by the user at will to heat-treat the required tissue area. The optical unit contains a focusing lens with a high transmission coefficient used to focus the light beam carried by the optical fibers on the tissue to be treated. In order to identify precisely the tissue area to be irradiated, it is important to have a guide light available (650nm red) with a beam collimated with the laser light beam. The guide light allows one to visualize the target site clearly. The red quide light has no therapeutic value.
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    K Number
    K023935
    Device Name
    TRILUMINA THERAPEUTIC LASER SYSTEM
    Date Cleared
    2003-01-28

    (63 days)

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

    TEXAS APPLIED BIOMEDICAL SERVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TriLumina Therapeutic Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
    Device Description
    The TriLumina Therapeutic Laser is an innovative, safe, easy to use, hand-held, battery operated, non-invasive, athermal low energy infrared laser device. The TriLumina Therapeutic Laser contains three gallium-aluminum-arsenide continuous wave diodes operating in the near infrared at a wavelength of 830 nanometers and a visible red light emitting diode is used as a quide beam. The device has a power output of 30 milliwatts for each GaAlAs diode with a noncollimating beam of dimensions of approximately 1 by 3 millimeters at the lens. The Laser has an "On / Off" switch to control the power to the device and two pressure switches that when pressed energize the laser diodes. A timer automatically times the 30 second activation cycle and the delivery of 3 Joules of energy.
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