9 results
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27ms
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Sources: EU EUDAMED, US FDA
LumiThera, Inc.
Manufacturer
🇺🇸 United States·1 Importer
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
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers