BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence Imaging For Breast Cancer Detection

    PMA: P230014 · Supplement: S004 · Decision Nov 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence Imaging For Breast Cancer Detection
    Trade Name
    Lumicell Direct Visualization System (DVS)
    PMA Number
    P230014
    Supplement Number
    S004
    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 25, 2025
    Date Received
    November 10, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the labeling including additional caution/warning/guidance statements and updated labeling to address corrective actions taken with respect to breaking or detachment of elastic bands from the device during use.

    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