Aesthetics Biomedical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0444-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: March 13, 2020

Date Posted: November 18, 2020

Recall Number: Z-0444-2021

Event ID: 85891

Reason for Recall:

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

Status: Terminated

Product Quantity: 623 units

Code Information:

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 Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated