Reported Jan 15, 2025 · Ongoing
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Ids Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IDS LTD · 194 Simgung-Ro · Paju · N/A
Is this the product you have?
- Smaxel Fractional CO2 Laser, a Class IV medical laser system.
- Lot codes and dates
- unknown
- Amount recalled
- 23
Where it was sold
- Nationwide
Why it was recalled
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
This product could cause temporary or reversible health problems — stop using it.
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