BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ulthera System

    Reg #: 3005646850 · FEI: 3005646850 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Jabil Inc.
    Registration Number
    3005646850
    FEI Number
    3005646850
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3800 GIDDINGS RD.
    City
    AUBURN HILLS
    State
    MI
    ZIP
    48326
    Country
    US

    Regulatory Submissions

    510(k) Number
    K134032

    Owner / Operator

    Firm Name
    Jabil Inc.
    Operator Number
    9074019
    Address
    10800 Roosevelt Blvd.
    City
    Saint Petersburg
    State
    FL
    Postal Code
    33716
    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 Ulthera

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)