FDA Enforcement
Class II
Ongoing
Diode Laser Hair Removal model: WLA-01
Recall: Z-0556-2025
·
Reported December 11, 2024
Enforcement
- Recall Number
- Z-0556-2025
- Event ID
- 95831
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- WINGDERM ELECTRO-OPTICS LTD.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- December 11, 2024
- Initiation Date
- August 23, 2024
- Classification Date
- December 5, 2024
- Address
- Room 312, Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District, Beijing, N/A, China
Description
Diode Laser Hair Removal model: WLA-01
Reason
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
Code Info
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution
Worldwide Distribution