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510(k) Data Aggregation

    K Number
    K083822
    Device Name
    LASER TOUCHONE
    Manufacturer
    LASER HEALTH TECHNOLOGIES, LLC
    Date Cleared
    2009-05-06

    (135 days)

    Product Code
    GZJ,NHN
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K822854,K032816,K081141,K883911
    Predicate For
    K100116
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LaserTouchOne™ is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of postsurgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

    Device Description

    The LaserTouchOne™ device is a rechargeable hand-held pain therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy is delivered with a single diode laser of

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the LaserTouchOne™ device, primarily focusing on its intended use, device description, comparison to predicate devices, and the FDA's substantial equivalence determination. It does not include details about specific performance metrics, clinical trial design, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

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