FDA Enforcement
Class II
Ongoing
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Recall: Z-0804-2025
·
Reported January 15, 2025
Enforcement
- Recall Number
- Z-0804-2025
- Event ID
- 96034
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- IDS LTD
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- January 15, 2025
- Initiation Date
- October 16, 2024
- Classification Date
- January 7, 2025
- Address
- 194 Simgung-Ro, Gwangtan-Myeon, Paju, N/A, Korea (the Republic of)
Description
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Reason
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Code Info
unknown
Distribution
Worldwide - US Nationwide Distribution
Quantity
23