Class II

Medical Device Recall: Smaxel Fractional CO2 Laser, a Class IV medical laser system.

IDS LTD · October 16, 2024

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

States Affected

NATIONWIDE

Quantity Affected

23

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0804-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

IDS LTD Medical Device Recall: Smaxel Fractional CO2 Laser, a Class IV medical laser system. | SafeCheck