ClearanceBrief
Recall Z-1558-2026 ยท GEX Powered Laser Surgical Instrument

Lutronic Corporation

CLARITY II Laser System; Model No. 1110200210.

DateMar 12, 2026 (initiated Jan 27, 2026)
StatusOpen, Classified
ReasonReports of devices sparking/popping and potentially burning patients.
Root causeDevice Design
Quantity1,525 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K183566CLARITY II Laser System
Lutronic Corporation, Jun 14, 2019