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IDS LTD recalls Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Recalled January 15, 2025 · FDA recall Z-0804-2025 · IDS
Hazard
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. · FDA Class II
Units
23
Sold at
Worldwide - US Nationwide Distribution
Description
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Product
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Manufacturer(s)
IDS LTD
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →