BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060011 · Supplement: S002 · Decision Nov 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C
    PMA Number
    P060011
    Supplement Number
    S002
    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
    November 22, 2011
    Date Received
    September 13, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 570C, AS WELL AS THE ADDITION OF A MODULATION TRANSFER FUNCTION (MTF) FIGURE TO THE PHYSICIANS LABELING COMPARING BOTH MODELS (I.E., 970C AND 570C).

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens