medical Class II Updated 2020-11-18

Aesthetics Biomedical, Inc. recalls SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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
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