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510(k) Data Aggregation

    K Number
    K021985
    Device Name
    MEDX LCS LASER SERIES
    Manufacturer
    MEDX ELECTRONICS, INC.
    Date Cleared
    2002-09-10

    (84 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K010175
    Why did this record match?
    Device Name :

    MEDX LCS LASER SERIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MedX LCS Laser Series is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with carpal tunnel syndrome.

    Device Description

    MedX LCS Laser Series primarily consists of a hand held portable laser device and the battery recharger. The hand held laser contains the laser diodes and assembly, circuit board, electronics, battery and labels. The power receptacle for the battery recharger is located at the base of the hand held laser.

    AI/ML Overview

    I'm sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study breakdown. The document is primarily a 510(k) summary for the MedX LCS Laser Series, focusing on its classification, predicate device, and FDA's substantial equivalence determination.

    It does not include:

    • Acceptance criteria for device performance.
    • Any study details, such as sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, or results of a comparative effectiveness study.
    • Standalone algorithm performance.

    Therefore, I cannot fulfill the request as the required information is not present in the provided text.

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