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

    Intraocular Lens

    PMA: P100016 · Supplement: S025 · Decision Jun 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    CT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P
    PMA Number
    P100016
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 10, 2026
    Date Received
    May 14, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    adding an alternate supplier of a raw material utilized in the composition of the adhesive used to manufacture three-piece intraocular lens (CT LUCIA 202 and CT LUCIA 602)

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens