Aesthetics Biomedical, Inc. recalls SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and s…

Recall date

March 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0444-2021

FDA classification

Class II

Brand / firm

Aesthetics Biomedical, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.