Recall archive / FDA device enforcement
Non-ablative Fractional Laser Systems, Model: WFB-01 — FDA record Z-0555-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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)
- Classification
- Class II
- Recalling firm
- WINGDERM ELECTRO-OPTICS LTD.
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0555-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 11, 2024
- Recall initiation date
- Aug 23, 2024
- Center classification date
- Dec 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.