Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Diode Laser Hair Removal System model: WLA01

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Diode Laser Hair Removal System model: WLA01see related information
Date Initiated by FirmAugust 23, 2024
Date PostedDecember 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0556-2025
Recall Event ID 95831
510(K)NumberK191611 
Product Classification Powered laser surgical instrument - Product Code GEX
Product Diode Laser Hair Removal model: WLA-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		All model WLA-01 systems sold to US customers are found to have labeling non-compliances
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 = GEX
-
-