BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P210005 · Supplement: S007 · Decision Apr 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Extended Depth Of Focus Intraocular Lens
    Trade Name
    IC-8 Apthera Intraocular Lens (IOL)
    PMA Number
    P210005
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    POE
    Generic Name
    Extended depth of focus intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 25, 2025
    Date Received
    December 6, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    approval for updating the Instructions for Use of the IC-8 Apthera Intraocular Lens (IOL) to include the outcomes of the Continuation Post-Approval Study (PAS) SAIL-101-PAS

    Classifications

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

    Product Code Device Name
    POE Extended Depth Of Focus Intraocular Lens