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510(k) Data Aggregation

    K Number
    K131797
    Device Name
    3B LASER NEEDLE
    Manufacturer
    LIVETEC GMBH
    Date Cleared
    2013-10-10

    (114 days)

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

    The 3B Laser Needle is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the request as it does not contain information about the acceptance criteria or a study proving that the device meets them. This document is an FDA 510(k) clearance letter for the 3B Laser Needle, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information, indications for use, and general controls, but it does not detail specific performance metrics, clinical study design, or results.

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