BEUDAMED
    Product Code: LNR FDA class 3

    System, Photopheresis, Extracorporeal

    Unknown

    System, Photopheresis, Extracorporeal is an extracorporeal photochemotherapy system in which blood is drawn from a patient, white blood cells (particularly T-lymphocytes) are exposed to a photoactivatable drug (such as 8-methoxypsoralen) and ultraviolet-A (UVA) light, and then returned to the patient, used in the treatment of cutaneous T-cell lymphoma and other immune-mediated conditions. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA). The product code is LNR; no regulation number has been assigned, and the review panel is Gastroenterology/Urology. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LNR
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.