FDA-Device2024-12-11Class II
Non-ablative Fractional Laser Systems, Model: WFB-01
WINGDERM ELECTRO-OPTICS LTD.
Hazard
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)
Sold states
Worldwide Distribution
Manufactured in
Room 312, Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District, Beijing, China
Products
Non-ablative Fractional Laser Systems, Model: WFB-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0555-2025Don't want to check this manually?
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