Recall Z-0555-2025— WINGDERM ELECTRO-OPTICS LTD.
Class II · Ongoing
Class II FDA medical device recall by WINGDERM ELECTRO-OPTICS LTD., initiated 2024-08-23. It names one FDA 510(k) clearance: K192350. Product: Non-ablative Fractional Laser Systems, Model: WFB-01. Reason: 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).
- Recalling firm
- WINGDERM ELECTRO-OPTICS LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-23
- Firm location
- Beijing, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Non-ablative Fractional Laser Systems, Model: WFB-01
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.