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510(k) Data Aggregation

    K Number
    K050342
    Device Name
    THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
    Manufacturer
    THERALASE INC.
    Date Cleared
    2005-07-11

    (150 days)

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

    THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM

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

    The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

    Device Description

    The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.

    AI/ML Overview

    Acceptance Criteria and Device Performance for Theralase™ TLC-1000 Therapeutic Medical Laser System

    1. Table of Acceptance Criteria and Reported Device Performance

    MetricAcceptance Criteria (Implied)Reported Device Performance
    Efficacy (Pain Relief)Statistically significant difference in pain reduction (VAO scores) between active laser and sham laser groups.p-value
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