BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P080004 · Supplement: S015 · Decision Jun 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)
    PMA Number
    P080004
    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
    June 16, 2014
    Date Received
    March 19, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN OPTICAL DESIGN CURVATURE MODIFICATION TO THE ISERT® MODEL 251 TO ADD A CONTROLLED POSITIVE SPHERICAL ABERRATION TO THE OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT® GEMETRIC MODEL 751 AND IS INDICATEDFOR IMPLANTATION AFTER EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION OF CATARACTS IN ADULTS. THIS LENS IS INTENDED FOR PLACEMENT 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