BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    VISULAS Trion Laser System with the VITE Option

    Reg #: 9615030 · FEI: 3001362763 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARL ZEISS MEDITEC AG (JENA)
    Registration Number
    9615030
    FEI Number
    3001362763
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Goeschwitzer Strasse 51-52
    City
    JENA Thuringia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K103056

    Owner / Operator

    Firm Name
    Carl Zeiss Meditec, Inc.
    Operator Number
    9053564
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    Postal Code
    94568
    Country
    US
    Correspondent
    Paul Swift

    US Agent

    Business Name
    CARL ZEISS MEDITEC USA, INC.
    Contact Name
    Paul Swift
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    ZIP
    94568
    Country
    US
    Email
    [email protected]
    Phone
    817 9258507

    Products

    Device Name Product Code
    Laser, Ophthalmic HQF

    Proprietary Names

    VISULAS Trion Laser System with the VITE Option

    Establishment Types

    Manufacture Medical Device