BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P060011 · Supplement: S025 · Decision Mar 26, 2021
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    RayOne EMV (Model RAO200E)
    PMA Number
    P060011
    Supplement Number
    S025
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 26, 2021
    Date Received
    August 14, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the RayOne EMV, Model RAO200E, which is a preloaded intraocular lens (IOL) injector system extending the RayOne family of one-piece IOLs that incorporate an optical modification.