Poulsbo, WA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| SDE | Light Based Device For Dry Age-Related Macular Degeneration | Class II | Ophthalmic | 1 | 2024-11-04 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-05-07 | Class III | Ongoing | Z-2046-2025 | Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Pro… | — | U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-11-04 | DEN230083 | Valeda Light Delivery System | SDE | Class II | Ophthalmic |