BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Supplement: S034 · Decision Oct 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Light Source System, Diagnostic Endoscopic
    Trade Name
    Photodynamic Diagnostic D-Light C System
    PMA Number
    P050027
    Supplement Number
    S034
    Device Class
    FDA Class 3
    Product Code
    OAY
    Generic Name
    Light source system, diagnostic endoscopic
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 1, 2025
    Date Received
    September 4, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to replace the backside mirror coating from RSM 3950100 to RSM 3950108

    Classifications

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

    Product Code Device Name
    OAY Light Source System, Diagnostic Endoscopic