BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ulthera System

    Reg #: 1012187 · FEI: 1012187 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ulthera Inc
    Registration Number
    1012187
    FEI Number
    1012187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6501 Six Forks Rd
    City
    Raleigh
    State
    NC
    ZIP
    27615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233996

    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

    Products

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

    Proprietary Names

    Ulthera System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility