Device product
Non-ablative Fractional Laser Systems, Model: WFB-01
Z-0555-2025
Product summary
- Event
- Event 95831
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0555-2025
Official wording
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)
Code information: F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Device software or design
software bug