MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A trained cynosure lutronic field service engineer (fse) went to the treatment provider site for a device evaluation.During this time, there was no evidence of observation of the device sparking made by the fse.The device was visually inspected for damage, and it was observed to have debris in the air filter and the handpiece (hp) filter, this was cleaned to correct the observation.It is unknown if this contributed to the reported issue.The customer was shown how to inspect and clean the hp filter.It was observed a grounding coil was not installed and the fse installed one, it is undetermined if this contributed to the reported issue.The device was subjected to full functionality testing with passing results.There was no indication of a device malfunction.A member of the cynosure lutronic clinical team made contact with the treatment provider and found that the treatment was performed on (b)(6) 2026 for telangiectasia on the nose.During the procedure, a loud pop was heard and observed with a bright spark, this was followed by what appeared to be a black charred area on the skin.There were no images taken of this, or of the patient by the treatment provider.The clinical team made multiple attempts to obtain additional patient details; however, these information requests went unanswered.It was confirmed that the icd 10/10/10 ms settings were used for treatment.To reduce the probability of reoccurrence the current clinical guidelines were reviewed in detail with the treatment provider.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 that during laser vascular treatment with a clarity ii device, a spark occurred followed by visible black "soot" on the skin.

• 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 01885
• MDR Report Key: 24567944
• Report Number: 3021199089-2026-00014
• Device Sequence Number: 9507277
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)241107
• 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): 03/11/2026

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: 02/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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
• Patient Age: 47 YR
• Patient Sex: Female