HIGH

CLARITY II Laser System; Model No. 1110200210.

Reports of devices sparking/popping and potentially burning patients.

Quick Facts at a Glance

Recall Date
January 27, 2026
Hazard Level
HIGH
Brand
Lutronic
Geographic Scope
1 states

Hazard Information

Reports of devices sparking/popping and potentially burning patients.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Lutronic Corporation or your healthcare provider for instructions. Notification method: E-Mail

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Full Description

CLARITY II Laser System; Model No. 1110200210.. Reason: Reports of devices sparking/popping and potentially burning patients.. Classification: Class II. Quantity: 1,525 units. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

Safety Guide

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Product Classification

Product Details

Model Numbers
Model No. 1110200210
UDI: 08809447653723
Serial No. C3023K024
C3022B006
C3025D028
+15 more
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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