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510(k) Data Aggregation

    K Number
    K080513
    Device Name
    QLASER SYSTEM
    Manufacturer
    2035, INC.
    Date Cleared
    2009-01-30

    (340 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K100116
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QLaser System is indicated for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the QLaser System, classifying it as an infrared lamp. It contains information about the device's regulatory status, indications for use, and general responsibilities under the Act. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, which are typically found in the 510(k) submission summary or associated documents, but not in the clearance letter itself. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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