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510(k) Data Aggregation

    K Number
    K030692
    Device Name
    POWER LASER 90
    Manufacturer
    ANDI ELECTROMEDICAL APS
    Date Cleared
    2003-07-17

    (134 days)

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

    ANDI ELECTROMEDICAL APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POWER LASER 90 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
    Device Description
    The POWER LASER 90 is a hand-held, battery operated, non-invasive, non-thermal, low energy, infrared laser, therapeutic medical device. A separate battery charger can recharge the battery when it is removed from the POWER LASER 90. POWER LASER 90 is a finished device, which is delivered packed with battery charger and complete labeling for the user.
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