FDA recall Z-0556-2025
WINGDERM ELECTRO-OPTICS LTD. · Class II · device
Product
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
Distribution
Worldwide Distribution
Key facts
- Status
- Ongoing
- Initiation date
- 2024-08-23
- Report date
- 2024-12-11
- Voluntary/Mandated
- FDA Mandated
- Location
- Beijing, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2025