Recall Z-2046-2025— LUMITHERA INC
Class III · Ongoing
Class III FDA medical device recall by LUMITHERA INC, initiated 2025-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet..
- Recalling firm
- LUMITHERA INC
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2025-05-07
- Firm location
- Poulsbo, WA, United States
Product description
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
Reason for recall
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Data sourced from openFDA. This site is unofficial and independent of the FDA.