Diode Laser Hair Removal Device Recalled for Labeling Non-Compliances
WINGDERM ELECTRO-OPTICS LTD. is recalling all WLA-01 diode laser hair removal systems sold to US customers due to labeling non-compliances.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a labeling non-compliance with no reported injuries or hospitalizations. Labeling errors on medical devices constitute minor documentation issues per the severity rubric, warranting a Moderate severity rating.
Plain-English summary
WINGDERM ELECTRO-OPTICS LTD. is recalling all model WLA-01 diode laser hair removal systems that were distributed to US customers. The recall was initiated by the FDA due to identified labeling non-compliances affecting all model WLA-01 systems sold to US customers.
Affected customers who own or operate a WLA-01 device should contact WINGDERM ELECTRO-OPTICS LTD. or their healthcare provider for information regarding the labeling non-compliance and any necessary corrective actions.
The recalled product
- Product
- Diode Laser Hair Removal model: WLA-01
- Manufacturer
- WINGDERM ELECTRO-OPTICS LTD.
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution
Distribution scope not specified by the agency.
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