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510(k) Data Aggregation

    K Number
    K080786
    Device Name
    ML830TP
    Manufacturer
    MICROLIGHT CORPORATION OF AMERICA
    Date Cleared
    2008-10-03

    (197 days)

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

    MICROLIGHT CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ML830®TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.
    Device Description
    The ML830 TP is a non-invasive, easy to use hand-held therapeutic device consisting of a probe containing battery-powered electronics that activate a single diode which delivers infrared energy. The probe is intended to be placed on or near the surface of the skin to provide temporary relief from pain.
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    K Number
    K041364
    Device Name
    ML830 LASER SYSTEM
    Manufacturer
    MICROLIGHT CORPORATION OF AMERICA
    Date Cleared
    2004-12-13

    (206 days)

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

    MICROLIGHT CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroLight ML830 d contains infrared lamps that are indicated for use 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, arthritis and muscle spasm; relieving stiffness; promoting relaxtion of pain, artifitis and inuscle spassily increase local blood circulation where applied.
    Device Description
    The ML830®d is an innovative, safe, easy to use, hand-held, non-invasive device The ML830 u is an innovative, sare, easy es approximately % pound and has a designed for in-nonic use. "The device worgine upper of these (34 square centimeters). The ML830®d contains 12 light emitting diodes and 12 infrared diodes with The NILGSV a commits TF ingile change wavelengths of 660 nanometers, and 880 nanometers, respectively, with total or waverongais of approximately 500 milliwatts.
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    K Number
    K010175
    Device Name
    MICROLIGHT 830 LASER SYSTEM
    Manufacturer
    MICROLIGHT CORPORATION OF AMERICA
    Date Cleared
    2002-02-06

    (384 days)

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

    MICROLIGHT CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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