BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence Imaging For Breast Cancer Detection

    PMA: P230014 · Decision Apr 17, 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 (DVS)
    PMA Number
    P230014
    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
    April 17, 2024
    Date Received
    April 14, 2023
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR the Lumicell Direct Visualization System. This device is a fluorescence imaging system intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The Lumicell Direct Visualization System is used with optical imaging agent LUMISIGHT (pegulicianine) for injection for fluorescence imaging of the lumpectomy cavity.

    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