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    K Number
    K030295
    Device Name
    LTU-904 PORTABLE LASER THERAPY UNIT
    Manufacturer
    RIANCORP PTY LTD
    Date Cleared
    2004-12-23

    (695 days)

    Product Code
    NZY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    NZY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LTU-904 is indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.
    Device Description
    The LTU-904 Laser Therapy Unit is a hand-held battery powered treatment device, is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye.
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