BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P080004 · Supplement: S016 · Decision Mar 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    CLARISERT PRELOADED IOL SYSTEM
    PMA Number
    P080004
    Supplement Number
    S016
    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
    March 31, 2017
    Date Received
    December 28, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes in the spherical aberration and thickness of the optic lens for your iSert® IOLs. You also requested approval for this lens to be distributed under a new private label under Bausch + Lomb Inc. as the ClarisertTM Preloaded IOL System (Model CLSRT).

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens