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510(k) Data Aggregation

    K Number
    K073689
    Device Name
    LEP2000 THERAPY SYSTEM
    Manufacturer
    INTERNATIONAL MEDICAL INSTRUMENTS, INC.
    Date Cleared
    2008-11-13

    (321 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for the LEP 2000 Photonic Therapy System. It describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets them.

    Therefore, I cannot provide the requested information based on this document. The document confirms the device is substantially equivalent to a predicate device, which allows it to be marketed, but does not detail the specific performance testing you're asking about.

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