Device recall
Z-0444-2021: SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage…
FDA device recall · Class II · Aesthetics Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0444-2021 |
|---|---|
| Recall event | 85891 |
| 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. |
| Product code | OUH |
| Recalling firm | Aesthetics Biomedical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2021 |
| 510(k) numbers | K150409 |
| FEI number | 3012204368 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database