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

    Intraocular Lens

    PMA: P060011 · Supplement: S042 · Decision Oct 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric, RayOne Aspheric RAO600C, RayOne Spheric RAO100C and RayOne EMV
    PMA Number
    P060011
    Supplement Number
    S042
    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
    October 1, 2025
    Date Received
    August 27, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the addition of a redundant moist heat (steam) sterilizer for routine sterilization of preloaded RayOne devices

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens