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Lutronic Corporation recalls CLARITY II Laser System; Model No. 1110200210.
Recalled March 18, 2026 · FDA recall Z-1558-2026 · Lutronic
Hazard
Reports of devices sparking/popping and potentially burning patients. · FDA Class II
Units
1,525 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
Description
Reports of devices sparking/popping and potentially burning patients.
Product
CLARITY II Laser System; Model No. 1110200210.
Manufacturer(s)
Lutronic Corporation
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →