Device recall enforcement reports

Diode Laser Hair Removal model: WLA-01

WINGDERM ELECTRO-OPTICS LTD. · All model WLA-01 systems sold to US customers are found to have labeling non-compliances

Class IIOngoingZ-0556-2025
Status
Ongoing
City
Beijing
Country
China
Classification
Class II
Product type
Devices
Event ID
95831
Recalling firm
WINGDERM ELECTRO-OPTICS LTD.
Address 1
Room 312
Address 2
Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District
Postal code
N/A
Voluntary mandated
FDA Mandated
Initial firm notification
Letter
Distribution pattern
Worldwide Distribution
Recall number
Z-0556-2025
Product description
Diode Laser Hair Removal model: WLA-01
Reason for recall
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
Recall initiation date
20240823
Center classification date
20241205
Report date
20241211
Code info
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.