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U.S. Department of Health and Human Services

Medical Device Recalls
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 Medical Device Recallssee related information
Date Initiated by FirmJanuary 27, 2026
Create DateMarch 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1558-2026
Recall Event ID 98372
ProductCLARITY II Laser System; Model No. 1110200210.
Recalling Firm/
Manufacturer		 Lutronic Corporation
219 Sowon-Ro; Deogyang
Goyang Korea (the Republic of)
For Additional Information ContactCynosure Lutronic Clinical Support
844-3655060
Manufacturer Reason
for Recall		Reports of devices sparking/popping and potentially burning patients.
Quantity in Commerce1,525 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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