Smaxel Fractional CO2 Laser, a Class IV medical laser system.
This recall is currently active, issued January 7, 2025. It was issued by Ids Ltd 194 Simgung-Ro Gwangtan-Myeon Paju Korea (The Republic Of).
- Recall Initiated
- October 16, 2024
- Posted
- January 7, 2025
- Recall Number
- Z-0804-2025
- Quantity
- 23
- Official Source
- View on FDA website ↗
Reason for Recall
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Distribution
Worldwide - US Nationwide Distribution
Lot / Code Info
unknown
Root Cause
Radiation Control for Health and Safety Act
Action Taken
IDS LTD recommend that users are advised to use it as close to the main body as possible during the procedure. The firm will without charge remedy the defect or bring the product into compliance with each applicable Federal standard. On or about 1/22/2025, the firm mailed a "Notification Letter" to affected customers/users informing them that the SAXEL Fractional CO2 Laser System does not have affixed a certification label and that the firm will be implementing a design change by revising the certification label and will provide the revised certification label free of charge following the design change.