Device recall
Z-0804-2025: Smaxel Fractional CO2 Laser, a Class IV medical laser system.
FDA device recall · Class II · IDS LTD
Key facts
| Recall number (Z-number) | Z-0804-2025 |
|---|---|
| Recall event | 96034 |
| Product | Smaxel Fractional CO2 Laser, a Class IV medical laser system. |
| Product code | ONG |
| Recalling firm | IDS LTD |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180036 |
| FEI number | 3012639861 |
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