BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ulthera System

    Reg #: 3013840437 · FEI: 3013840437 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Merz North America, Inc.
    Registration Number
    3013840437
    FEI Number
    3013840437
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    13900 W. Grandview Parkway
    City
    Sturtevant
    State
    WI
    ZIP
    53177
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180623

    Owner / Operator

    Firm Name
    Merz North America, Inc.
    Operator Number
    9043404
    Address
    6501 Six Forks Road
    City
    Raleigh
    State
    NC
    Postal Code
    27615
    Country
    US
    Correspondent
    Bonnie Safyurtlu

    Products

    Device Name Product Code
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Ulthera System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198