Recall Z-0444-2021— Aesthetics Biomedical, Inc.
Class II · Terminated
Class II FDA medical device recall by Aesthetics Biomedical, Inc., initiated 2020-03-13, terminated 2021-09-01. It names one FDA 510(k) clearance: K150409. 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.. Reason: A high frequency output (2 MHz) has not been cleared for distribution in the U.S..
- Recalling firm
- Aesthetics Biomedical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-13
- Terminated
- 2021-09-01
- Firm location
- Phoenix, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Data sourced from openFDA. This site is unofficial and independent of the FDA.