Wingderm Electro-Optics Ltd. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Diode Laser Hair Removal model: WLA-01Class IIAug 23, 2024All model WLA-01 systems sold to US customers are found to h	All model WLA-01 systems sold to US customers are found to have labeling non-compliances	Class IIDevices	Aug 23, 2024
Non-ablative Fractional Laser Systems, Model: WFB-01Class IIAug 23, 2024Model WFB-01 sold to US customers before Aug 23, 2022 has be	Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB	Class IIDevices	Aug 23, 2024