BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P100016 · Supplement: S023 · Decision Mar 20, 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
    S023
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 20, 2026
    Date Received
    November 17, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change in the heated aeration room used for the aeration phase of the routine Ethylene Oxide (EO) sterilization process, and dissipation of EO sterilant residuals, for product sterilized in Chamber #1 at the existing sterilization site

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens