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510(k) Data Aggregation

    K Number
    K153052
    Device Name
    Erchonia PL Touch
    Manufacturer
    ERCHONIA CORPORATION
    Date Cleared
    2016-01-04

    (76 days)

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

    The Erchonia® PL Touch laser is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Erchonia® PL-Touch laser. It confirms that the device is substantially equivalent to legally marketed predicate devices for the indicated use of temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

    However, this document does not contain information on the acceptance criteria, specific device performance data from a study, sample sizes, expert qualifications, adjudication methods, or ground truth details as requested. The letter is an administrative clearance document and does not include the technical study details typically found in a clinical trial report or a summary of safety and effectiveness (SSE).

    Therefore, I cannot provide the requested table and information based on the given input.

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