BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060011 · Supplement: S014 · Decision Nov 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses
    PMA Number
    P060011
    Supplement Number
    S014
    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 14, 2018
    Date Received
    April 2, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing process improvements for all Rayner FDA-approved Intraocular Lenses (IOLs) and a new packaging configuration for your 6.0 mm Aspheric IOL, Model 600C, into a preloaded injector.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens