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    K Number
    K081166
    Device Name
    LIGHTSTREAM LOW LEVEL LASER
    Manufacturer
    SOLICA CORPORATION
    Date Cleared
    2009-04-03

    (344 days)

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

    SOLICA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightStream Low Level Laser device is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
    Device Description
    The LightStream Laser is a handheld, non-invasive, low energy, non thermal infrared therapeutic medical laser. The LightStream Laser System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe with one laser tip and one cluster probe with 5 laser tips. The device incorporate Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering 60mW at the 903 nanometer (nm) wavelength, classifying it under under 21 CFR 890.5500, NHN as non-heating infrared lamp for adjunctive use in pain therapy. The LightStream is a non thermal device and is intended to be for adjunctive use in pain therapy and is not intended to provide therapeutic topical heating.
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