WINGDERM ELECTRO-OPTICS LTD.: Device Recall

Recall #Z-0555-2025 · 08/23/2024

Class II: Risk

Recall Details

Recall Number: Z-0555-2025
Classification: Class II
Product Type: Device
Recalling Firm: WINGDERM ELECTRO-OPTICS LTD.
Status: Ongoing
Date Initiated: 08/23/2024
Location: Beijing, China
Voluntary/Mandated: FDA Mandated

Reason for Recall

Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)

Product Description

Non-ablative Fractional Laser Systems, Model: WFB-01

Distribution Pattern

Worldwide Distribution

Other Recalls by WINGDERM ELECTRO-OPTICS LTD.

Class II: Risk 08/23/2024

All model WLA-01 systems sold to US customers are found to have labeling non-compliances

View all recalls by WINGDERM ELECTRO-OPTICS LTD. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.