Class II

Medical Device Recall: Non-ablative Fractional Laser Systems, Model: WFB-01

WINGDERM ELECTRO-OPTICS LTD. · August 23, 2024

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)

Distribution

Worldwide Distribution

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0555-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.