Recall Z-0556-2025 ยท GEX Powered Laser Surgical Instrument
WINGDERM ELECTRO-OPTICS LTD.
Diode Laser Hair Removal model: WLA-01
| Date | Dec 5, 2024 (initiated Aug 23, 2024) |
| Status | Open, Classified |
| Reason | All model WLA-01 systems sold to US customers are found to have labeling non-compliances |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The firm sent a notification letter to the relevant distribution on June 6, 2024. Products sold before August 23, 2022, will require a software version upgrade to F1-B-1.1.012 or Higher. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191611 | Diode Laser Therapy Systems Wingderm Electro-Optics , Ltd., Jul 31, 2019 |