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Open, Classified

Diode Laser Hair Removal model: WLA-01

FDA Recall Z-0556-2025 · Posted 2024-12-05

Recalling FirmWINGDERM ELECTRO-OPTICS LTD.
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2024-08-23

Reason for Recall

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

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191611Diode Laser Therapy SystemsWingderm Electro-Optics , Ltd. · 2019-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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