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

    Intraocular Lens

    PMA: P060011 · Supplement: S040 · Decision Apr 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
    PMA Number
    P060011
    Supplement Number
    S040
    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
    April 9, 2025
    Date Received
    March 18, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    use of the new storage facility for C-flex Intraocular Lens (IOL) (model 570C), C-flex Aspheric IOL (model 970C), 6.0 mm Aspheric IOL (model 600C), RayOne Aspheric IOL (model RAO600C), RayOne Spheric IOL (model RAO100C) and RayOne EMV IOL (model RAO200E)

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens