BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P910056 · Supplement: S051 · Decision Aug 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    enVista Hydrophobic Acrylic Intraocular Lens
    PMA Number
    P910056
    Supplement Number
    S051
    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
    August 21, 2023
    Date Received
    January 17, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the introduction of the UV + Duo material across the entire enVista® IOL portfolio along with the additions to the model number configurations, introduction of two additional IOL models (the enVista® ASPIRE monofocal [EA] and the enVista® ASPIRE toric [ETA]), and the inclusion of the option to have an electronic Instructions for Use (eIFU).

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens