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U.S. Department of Health and Human Services

Class 3 Device Recall Valeda Light Delivery System

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 Class 3 Device Recall Valeda Light Delivery Systemsee related information
Date Initiated by FirmMay 07, 2025
Date PostedJune 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2046-2025
Recall Event ID 96892
Product Classification Light based device for dry age-related macular degeneration - Product Code SDE
ProductBrand 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
Code Information Lot Code: UDI-DI +B749200001030/$$+720172/16D20250311T; Serial Number 20172 UDI-DI +B749200001030/$$+720166/16D20250311W; Serial Number 20166 UDI-DI +B749200001030/$$+720167/16D20250311X; Serial Number 20167 UDI-DI +B749200001030/$$+720168/16D20250311Y; Serial Number 20168 UDI-DI +B749200001030/$$+720169/16D20250311Z; Serial Number 20169 UDI-DI +B749200001030/$$+720175/16D20250311W; Serial Number 20175 UDI-DI +B749200001030/$$+720177/16D20250311Y; Serial Number 20177 UDI-DI +B749200001030/$$+720178/16D20250311Z; Serial Number 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R; Serial Number 20170
FEI Number 3016232028
Recalling Firm/
Manufacturer		 LUMITHERA INC
19578 10th Ave Ne Ste 200
Poulsbo WA 98370-7332
For Additional Information ContactTracy Puckett
844-3423333
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce8
DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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