BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ulthera

    Reg #: 3006560326 · FEI: 3006560326 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ULTHERA, INC.
    Registration Number
    3006560326
    FEI Number
    3006560326
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1840 South Stapley Drive Suite 200
    City
    Mesa
    State
    AZ
    ZIP
    85204
    Country
    US

    Regulatory Submissions

    510(k) Number
    K134032

    Owner / Operator

    Firm Name
    Ulthera, Inc.
    Operator Number
    10030422
    Address
    1840 South Stapley Drive, Suite 200
    City
    Mesa
    State
    AZ
    Postal Code
    85204
    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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility