BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence Imaging For Breast Cancer Detection

    PMA: P230014 · Supplement: S002 · Decision Nov 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Fluorescence Imaging For Breast Cancer Detection
    Trade Name
    Lumicell Direct Visualization System
    PMA Number
    P230014
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    SAW
    Generic Name
    Fluorescence imaging for breast cancer detection
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 26, 2024
    Date Received
    September 17, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a trim-potentiometer to the electrical circuit of the light source and addition of a component-level power specification.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SAW Fluorescence Imaging For Breast Cancer Detection