LUMITHERA INC
FDA Regulatory Profile
LUMITHERA INC appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2046-2025, Class III) was initiated on May 7, 2025. Its most recent 510(k) clearance was granted on November 4, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2046-2025 | Class III | Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macul | May 7, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN230083 | Valeda Light Delivery System | November 4, 2024 |