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510(k) Data Aggregation

    K Number
    K032787
    Device Name
    NEUROLASE, MODELS 150V, 150C, 1064
    Manufacturer
    SPECTRUM LASER & TECHNOLOGIES
    Date Cleared
    2003-11-20

    (73 days)

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

    **SPECTRUM LASER **& TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neurolase™ devices are an infrared lamp per 21 CFR 890.5500 that emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature to provide temporary relief of minor muscles and joint pain and stiffness, minor pain and stiffness associated with arthritis, or muscle spasm. These devices may temporarily increase blood circulation, and may be used to promote relaxation of muscle tissue.
    Device Description
    The Neurolase™ devices consist of a control unit and a handpiece The control unit houses the power supply, control electronics, calibration port, and infrared radiation source. The source is coupled to a fiber optic cable that delivers the energy to the patient through the handpiece.
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