Device recall
Z-2046-2025: Brand Name: Valeda Light Delivery System Product Name: Light Based Device for…
FDA device recall · Class III · LUMITHERA INC
Key facts
| Recall number (Z-number) | Z-2046-2025 |
|---|---|
| Recall event | 96892 |
| Product | Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No |
| Product code | SDE |
| Recalling firm | LUMITHERA INC |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 3016232028 |
At a glance
- None 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