BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060011 · Supplement: S036 · Decision Feb 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Rayner c .. flex 570C, C-flex Aspheric 97 C, 600C Aspheric lntraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric R
    PMA Number
    P060011
    Supplement Number
    S036
    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
    February 12, 2024
    Date Received
    November 13, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    changes to the primary packaging configuration, secondary outer carton packaging, and instructions for use labeling for your preloaded subject 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