LUMITHERA INC recalls Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age…

U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

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

On 05/08/2025, the firm initiated sending customers an "Valeda - Return" email to inform them that the Valeda system that was distributed to them was sent with the wrong configuration. Customer were instructed to use the attached return label and return the systems back to LumiThera.

• FDA enforcement recordOfficial FDA database entry for Z-2046-2025
• FDA device classification · SDEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.5520The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find LUMITHERA INCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.