BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LTU-904 PORTABLE LASER THERAPY UNIT

    K Number: K030295 · Decision Dec 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    695

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    Basic Information

    Device Name
    LTU-904 PORTABLE LASER THERAPY UNIT
    K Number
    K030295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Riancorp Pty, Ltd.
    Date Received
    January 28, 2003
    Decision Date
    December 23, 2004
    Product Code
    NZY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZY Light, Lymphedema Reduction, Low Energy