MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A member of the cynosure lutronic clinical team made contact with the treatment provider and found that vessel treatment is currently not an approved treatment in canada.Additionally, the icd settings used for treatment were 10/20/10 and these settings have recently been updated to 10/20/10, it is possible that the treatment settings contributed to the spark and burn, however, it cannot be confirmed.To reduce the probability of reoccurrence the treatment provider was informed that vascular lesion treatments over 60 j/cm2 should utilize an icd setting of 10/10/10 per the recent update.A customer letter has since gone out to notify customers of this recommended setting update.The event is reportable per fda medical device reporting title 21 cfr part 803 since a malfunctioned occurred and would likely cause or contribute to a serious injury if the malfunction were to recur.
Event or Problem Description
It was reported on (b)(6) 2026 that during vessel treatment with a clarity ii device performed on (b)(6) 2026, the device sparked, left a black mark on the patients chin that was wiped away and burn where the black mark was.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer (Section G): LUTRONIC CORPORATION; lutronic center; 219, sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 5 carlisle rd; westford, MA 01886
• MDR Report Key: 24389658
• Report Number: 3021199089-2026-00007
• Device Sequence Number: 21488278
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: 08809447653723
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female