IDS LTD recalls Smaxel Fractional CO2 Laser

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0804-2025
• FDA 510(k) clearance · K180036The device's official FDA premarket clearance record
• FDA device classification · ONGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4810The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find IDS LTDSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.