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510(k) Data Aggregation

    K Number
    K151816
    Device Name
    TLC-2000 Therapeutic Medical Laser System
    Manufacturer
    Theralase Inc.
    Date Cleared
    2015-11-19

    (136 days)

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

    TLC-2000 Therapeutic Medical Laser System

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

    The Theralase TLC-2000 Therapeutic Medical Laser System is in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary from the FDA for a medical device. It does not contain the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that you requested. The document primarily focuses on the substantial equivalence determination for regulatory purposes.

    Therefore, I cannot fulfill your request to create the table and answer the specific questions about the device's acceptance criteria and the study that proves it meets them.

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