LUMITHERA INC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2046-2025Class IIIBrand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related MaculMay 7, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
DEN230083Valeda Light Delivery SystemNovember 4, 2024