Lutronic Corporation recalls CLARITY II Laser System; Model No. 1110200210.

Recall date

January 27, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1558-2026

FDA classification

Class II

Brand / firm

Lutronic Corporation

Sold / distributed

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

Why it was recalled

Reports of devices sparking/popping and potentially burning patients.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CLARITY II Laser System; Model No. 1110200210.