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U.S. Department of Health and Human Services

Class 2 Device Recall Nonablative Fractional Laser model: WFB01

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 Class 2 Device Recall Nonablative Fractional Laser model: WFB01see related information
Date Initiated by FirmAugust 23, 2024
Date PostedDecember 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0555-2025
Recall Event ID 95831
510(K)NumberK192350 
Product Classification Powered laser surgical instrument with microbeam\fractional output - Product Code ONG
ProductNon-ablative Fractional Laser Systems, Model: WFB-01
Code Information F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
FEI Number 3014310779
Recalling Firm/
Manufacturer		 WINGDERM ELECTRO-OPTICS LTD.
Room 312
Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District
Beijing China
For Additional Information ContactJuan Zhou
86-01062910812
Manufacturer Reason
for Recall		Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
Action The firm sent a notification letter to the relevant distribution on June 6, 2024. Products sold before August 23, 2022, will require a software version upgrade to F1-B-1.1.012 or Higher.
Distribution Worldwide Distribution
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.
510(K) Database510(K)s with Product Code = ONG
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