BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P910061 · Supplement: S015 · Decision Dec 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    LI61AO LENS
    PMA Number
    P910061
    Supplement Number
    S015
    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
    December 6, 2006
    Date Received
    August 30, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD A STATEMENT TO THE DIRECTIONS FOR USE THAT THE SOFPORT MODEL LI61 AO IOL HAS PROLATE ASPHERIC SURFACES AND IS DESIGNED TO BE FREE OF SPHERICAL ABERRATIONS, AND TO ADD A FIGURE WITH THE MODULATION TRANSFER FUNCTIONS FOR THE LI61AO AND LI61SE LENSES.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens