6 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUMITHERA, INC.
FDA registration
LUMITHERA, INC.·1 product·🇺🇸 United States
Valeda Light Delivery System
FDA UDI
LUMITHERA, INC.·B749200002010·
VALEDA LIGHT DELIVERY SYSTEM
FDA Adverse Event
Injury
·LUMITHERA, INC.·Product code SDE·November 25, 2025
VALEDA LIGHT DELIVERY SYSTEM
FDA Adverse Event
Injury
·LUMITHERA, INC.·Product code SDE·September 15, 2025
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
FDA Recall
Open, Classified
·LUMITHERA INC·Product code SDE·May 7, 2025
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
FDA Enforcement
Class III
·Ongoing·LUMITHERA INC·July 9, 2025