BEUDAMED
    FDA Enforcement Class II Terminated

    SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

    Recall: Z-0444-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0444-2021
    Event ID
    85891
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesthetics Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 18, 2020
    Initiation Date
    March 13, 2020
    Classification Date
    November 12, 2020
    Termination Date
    September 1, 2021
    Address
    4602 N 16th St Ste 300, Phoenix, AZ, 85016-5162, United States

    Description

    SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

    Reason

    A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

    Code Info

    UDI Code: 08800017100326 All Lots/Serial Numbers: Serial Number range from 16019 to 20121. The Vivace Electrosurgical System is controlled by software system: VIVA-MA-01, V 1.0, Class B

    Distribution

    U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

    Quantity

    623 units