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510(k) Data Aggregation

    K Number
    K053507
    Device Name
    ELITE ELECTROMED L.I.T.E. 4/1
    Manufacturer
    ELITE ELECTROMEDICAL
    Date Cleared
    2006-03-15

    (89 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 L.I.T.E. 4/1 IS INDICATED FOR THE TREATMENT OF NECK AND SHOULDER PAIN OF MUSCULOSKELET OF ORIGIN.

    Device Description

    Not Found

    AI/ML Overview

    This document is correspondence from the FDA regarding a 510(k) premarket notification for a medical device. It does NOT contain information about acceptance criteria, study details, or performance metrics for the device. Therefore, I cannot extract the requested information.

    The document indicates that the device, "Elite Electromedical L.I.T.E. 4/1 Diode Laser," is substantially equivalent to legally marketed predicate devices for the treatment of neck and shoulder pain of musculoskeletal origin. However, the letter does not provide any performance data or study details to support this determination.

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