FDA Medical devices recall ·
Diode Laser Hair Removal model: WLA-01 recall
- Recall number
- Z-0556-2025
- Date
- (initiated August 23, 2024)
- Company / brand
- Wingderm Electro-Optics Ltd.
Room 312, Beijing, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Diode Laser Hair Removal model: WLA-01
Why was it recalled?
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution
Worldwide Distribution
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0556-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.