BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vivace Ultra RF Microneedling System

    Reg #: 3012204368 · FEI: 3012204368 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    AESTHETICS BIOMEDICAL INC.
    Registration Number
    3012204368
    FEI Number
    3012204368
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7227 N 16th St Ste 160
    City
    Phoenix
    State
    AZ
    ZIP
    85020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221574

    Owner / Operator

    Firm Name
    Aesthetics Biomedical Inc.
    Operator Number
    10051282
    Address
    4602 North 16th Street, Suite 300
    City
    Phoenix
    State
    AZ
    Postal Code
    85016
    Country
    US
    Correspondent
    Shaun Wootten

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Skin Resurfacing Rf Applicator OUH
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Vivace Ultra RF Microneedling System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device