Device recall
Z-1290-2025: (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse…
FDA device recall · Class II · LUMENIS, LTD.
Key facts
| Recall number (Z-number) | Z-1290-2025 |
|---|---|
| Recall event | 96197 |
| Product | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System. |
| Product code | GEX |
| Recalling firm | LUMENIS, LTD. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170121 |
| FEI number | 3004135191 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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