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510(k) Data Aggregation

    K Number
    K073689
    Device Name
    LEP2000 THERAPY SYSTEM
    Date Cleared
    2008-11-13

    (321 days)

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

    INTERNATIONAL MEDICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LEP2000 Photonic Therapy System is a device that emits energy in the infrared spectrum and is indicated for adjunctive use in providing temporary relief joint pain.
    Device Description
    The LEP2000 Photonic Therapy System is a device that emits energy in the infrared spectrum.
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