FDA-Device2025-01-15Class II
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
IDS LTD
Hazard
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Sold states
Worldwide - US Nationwide Distribution
Affected count
23
Manufactured in
194 Simgung-Ro, Gwangtan-Myeon, Paju, Korea (the Republic of)
Products
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2025Don't want to check this manually?
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