Boulder, CO, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 2 | 2024-10-11 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-12-06 | Class II | Ongoing | Z-0778-2024 | Accure Laser System, Model: PFMS00004 | — | Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, w… |