Device recall
Z-1558-2026: CLARITY II Laser System; Model No. 1110200210.
FDA device recall · Class II · Lutronic Corporation
Key facts
| Recall number (Z-number) | Z-1558-2026 |
|---|---|
| Recall event | 98372 |
| Product | CLARITY II Laser System; Model No. 1110200210. |
| Product code | GEX |
| Recalling firm | Lutronic Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183566 |
| FEI number | 3004483538 |
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