Beijing, CN · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 1 | 2026-02-24 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | Class II | General, Plastic Surgery | 1 | 2020-04-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-08-23 | Class II | Ongoing | Z-0556-2025 | Diode Laser Hair Removal model: WLA-01 | — | All model WLA-01 systems sold to US customers are found to have labeling non-compliances |
| 2024-08-23 | Class II | Ongoing | Z-0555-2025 | Non-ablative Fractional Laser Systems, Model: WFB-01 | — | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labe… |