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Recall Observatory FDA recall evidence

Device product

Diode Laser Hair Removal model: WLA-01

Z-0556-2025

August 23, 2024

Class II

Product summary

Firm
WINGDERM ELECTRO-OPTICS LTD.
Event
Event 95831
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0556-2025

Official wording

Reason: All model WLA-01 systems sold to US customers are found to have labeling non-compliances

Code information: F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    All model WLA-01 systems sold to US customers are found to have labeling non-compliances