Phoenix, AZ, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 1 | 2022-10-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-03-13 | Class II | Terminated | Z-0444-2021 | SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and s… | — | A high frequency output (2 MHz) has not been cleared for distribution in the U.S. |