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510(k) Data Aggregation

    K Number
    K033986
    Device Name
    MLT-1000 IR LASER SYSTEM
    Manufacturer
    MEDICAL LASER THERAPEUTICS LP
    Date Cleared
    2004-03-29

    (97 days)

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

    MEDICAL LASER THERAPEUTICS LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MLT - 1000 IR Laser System is 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 promoting relaxation of muscle.
    Device Description
    The MLT - 1000 IR Laser System is an innovative, safe, easy to use, hand-held, non-invasive therapeutic device that provides continuous heat therapy. The System consists of a Control Unit that houses the electronics and controls and a treatment probe hand piece that delivers the infrared energy.
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