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510(k) Data Aggregation

    K Number
    K083560
    Device Name
    EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
    Date Cleared
    2008-12-11

    (9 days)

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

    LIGHTHOUSE TECHNICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Expanded Spectrum Photo Therapy Device (ESPT-3X) is intended 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 and stiffness, . - minor arthritis pain, . - muscle spasm, 0 - the temporary increase in local blood circulation and/or . - promoting relaxation of muscle. . The ESPT-3X is for prescription use only.
    Device Description
    The ESPT-3X console is a non-invasive, portable, therapeutic medical laser designed to deliver high level (Class IV) energy/power for the purpose of reducing musculoskeletal pain. A "hand piece" accessory evenly delivers a Class IV laser to the target tissue. This channel is equipped with a red aiming beam (1 mW) that provides visible illumination of the area being treated. The console is equipped with a separate and independent timer that is manually set by the operator.
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