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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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.
Part of a larger recall action
This product is one of 2 recalled by WINGDERM ELECTRO-OPTICS LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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