Smaxel CO2 Laser (IDS) – Certification Labeling Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Brand
IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of)
Lot Codes / Batch Numbers
unknown
Products Sold
unknown
IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of) is recalling Smaxel Fractional CO2 Laser, a Class IV medical laser system. due to The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026