Z-0556-2025 Class II Ongoing
FDA device recall Z-0556-2025 was initiated by WINGDERM ELECTRO-OPTICS LTD. on August 23, 2024 and is designated Class II. Reason for recall: All model WLA-01 systems sold to US customers are found to have labeling non-compliances The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- August 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
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
Distribution Pattern
Worldwide Distribution
Code Information
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001