BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060011 · Supplement: S005 · Decision May 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    600C ASPHERIC INTRAOCULAR LENS
    PMA Number
    P060011
    Supplement Number
    S005
    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 1, 2015
    Date Received
    February 2, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS OF THE C-FLEX ASPHERIC IOL MODEL 970C: 1) INCREASE OF OVERALL DIAMETER FROM 12.00 MM TO 12.50 MM; 2) INCREASE OF OPTIC SIZE FROM 5.75 MM TO 6.00 MM; AND 3) AN EXTENSION OF THE HIGH POWERED DIOPTRIC RANGE FROM +30.0D TO +34.0D. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 600C ASPHERIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATIONTHE LENS IS INTENDED TO BE PLACED 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