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Aesthetics Biomedical, Inc. recalls SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and s
Recalled November 18, 2020 · FDA recall Z-0444-2021 · Aesthetics Biomedical
Hazard
A high frequency output (2 MHz) has not been cleared for distribution in the U.S. · FDA Class II
Units
623 units
Sold at
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.
Description
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Product
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.
Manufacturer(s)
Aesthetics Biomedical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →