Device product
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Z-0804-2025
Product summary
- Firm
- IDS LTD
- Event
- Event 96034
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-0804-2025
Official wording
Reason: The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Code information: unknown
Distribution pattern: Worldwide - US Nationwide Distribution
Derived failure modes
-
Unknown
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.