BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P090022 · Decision Apr 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
    PMA Number
    P090022
    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
    April 12, 2010
    Date Received
    September 1, 2009
    Expedited Review
    N
    Docket Number
    10M-0220

    Advisory Committee Statement

    APPROVAL FOR THE SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL). THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR BAG PLACEMENT.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens