Class II

Medical Device Recall: CLARITY II Laser System; Model No. 1110200210.

Lutronic Corporation · January 27, 2026

Reason for Recall

Reports of devices sparking/popping and potentially burning patients.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

States Affected

NATIONWIDE

Quantity Affected

1,525 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1558-2026

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.