FDA-Device2026-03-18Class IIPROCESSING DEFECT
Lutronic CLARITY II Laser System recalled for sparking and burn hazard
Stop using Lutronic CLARITY II Laser System
The Lutronic CLARITY II Laser System (Model 1110200210) may spark or pop during use, potentially causing burns to patients. The FDA has identified over 1,500 affected units based on serial number.
- Stop using the device immediately if you own or operate one of the affected serial numbers.
- Contact Lutronic Corporation for instructions on safe return or replacement.
- Check the device serial number against the recall list to confirm if your unit is affected.
Hazard
Reports of devices sparking/popping and potentially burning patients.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
Affected count
1,525 units
Manufactured in
219 Sowon-Ro; Deogyang, N/A, Goyang, N/A, Korea (the Republic of)
Products
CLARITY II Laser System; Model No. 1110200210.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2026Don't want to check this manually?
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