BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060011 · Decision May 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
    PMA Number
    P060011
    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
    May 3, 2007
    Date Received
    March 15, 2006
    Expedited Review
    N
    Docket Number
    07M-0189

    Advisory Committee Statement

    APPROVAL FOR THE C-FLEX MODEL 570C INTRAOCULAR LENS (IOL). THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICA-TION. THE LENS IS INTENDED TO BE PLACE IN THE CAPSULAR BAG.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens