FDA-Device2025-07-09Class III
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
LUMITHERA INC
Hazard
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Sold states
US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Affected count
8
Manufactured in
19578 10th Ave Ne Ste 200, Poulsbo, WA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2046-2025Don't want to check this manually?
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