LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K111901
    Device Name
    ASA 'MPHI FAMILY DIODE LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2011-11-09

    (127 days)

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

    The ASA 'Mphi Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of 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

    The ASA 'Mphi Family' Diode Lasers provides 808 and 905 nm wavelengths. Laser emission activation is by the user selectable controller. Electrical requirement is 110-250VAC, 50VA, 50-60Hz, single phase or battery mode.

    AI/ML Overview

    The provided text is a 510(k) summary for the ASA 'Mphi Family' Diode Laser. It explicitly states:

    "Nonclinical Performance Data: none"
    "Clinical Performance Data: none"

    Therefore, there is no information within the provided document to address any of the points regarding acceptance criteria or a study proving the device meets those criteria. The submission relies entirely on demonstrating substantial equivalence to a predicate device, which had "the same indications for use, the same principle of operation, and identical performance specifications."

    Conclusion:

    Based on the provided K111901 document, there is no information available regarding acceptance criteria or a study demonstrating the device meets such criteria. The submission is based solely on a comparison to a predicate device, and it explicitly states that no nonclinical or clinical performance data was provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1