Recall Z-0804-2025 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
IDS LTD
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
| Date | Jan 7, 2025 (initiated Oct 16, 2024) |
| Status | Open, Classified |
| Reason | The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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 des |
| Quantity | 23 |
| Distribution | Worldwide - US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180036 | SMAXEL CO2 Surgical Laser System Ids, Ltd., Feb 2, 2018 |