BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P100016 · Supplement: S004 · Decision Aug 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    CT LUCIA 202 IOL and CT LUCIA 602 IOL
    PMA Number
    P100016
    Supplement Number
    S004
    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
    August 9, 2017
    Date Received
    May 22, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for change in product name from Aaris® EC-3 and Aaris® EC-3 PAL to CT LUCIA 202 and CT LUCIA 602 respectively; minor product labeling changes to include the unit container box, adhesive label, Instructions for Use and patient card; and a new contact/manufacturing address.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens