BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P080004 · Supplement: S045 · Decision Jun 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    iSert Preloaded IOL System, IPure™ Preloaded IOL System
    PMA Number
    P080004
    Supplement Number
    S045
    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 22, 2023
    Date Received
    July 21, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at HOYA Lamphun Ltd., 725 Moo 4, Tambol Banklang, Amphur Muagn, Lamphun 5100, Thailand. Manufacturing processes will be limited to lathe cutting through primary packaging, shipment to and from sterilizer, Siam Steri Service Co. LTD, secondary packaging, and distribution of intraocular lenses (IOLs) and injector cartridges.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens