FDA-Device2020-11-18Class II
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.
Aesthetics Biomedical, Inc.
Hazard
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Sold states
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.
Affected count
623 units
Manufactured in
4602 N 16th St Ste 300, Phoenix, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0444-2021Don't want to check this manually?
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