BEUDAMED
    Product Code: SDA FDA class 3

    Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

    Unknown

    Electrical tumor treatment fields for non-small cell lung cancer (product name Optune Lua) is a Class III device (PMA required) intended for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen, used concurrently with PD-1/PD-L1 inhibitors or docetaxel. As a Class III device without an assigned regulation number, it required Premarket Approval, reflecting the high-risk and novel nature of electric field-based oncology therapy. The product code is SDA, reviewed by the Anesthesiology panel; the device is flagged as life-sustaining but is not an implant.

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    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    SDA
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    AN
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.