MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A trained cynosure lutronic field service engineer went to the treatment provider site for a device evaluation.During this time, the reported issue was unable to be duplicated.The device was subjected to multiple tests including full functionality testing, energy tests and full visual inspection with no discrepancies observed.The device was found to be working within published specifications.It is undetermined what caused the reported incident.A member of the cynosure lutronic clinical team made contact with the treatment provider and determined that the provider treated the patient with an off label indication at their own discretion.It is unknown if this contributed to the reported loud pop, spark and black mark that was reported to be left on the patient, or the red mark that remained on the patients nose one month post treatment.To reduce the probability of reoccurrence, the most recent device quick start guide was sent to the treatment site.Cryogen is applied to the treatment site during vascular treatment to precool the skin.The cryogen begins to vaporize from the surface of the skin shortly after contact.The laser fires onto the surface of the skin after a delay time.The spark/ignition events occur when residual cryogen vapors remaining on the skin surface interact with the high-energy 1064 nm laser fluence.Longer pre-cooling and delay times increase the likelihood of uneven vapor accumulation, thereby elevating the risk of ignition.This can be observed as a spark and can result in topical burn.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 vessel treatment on the nose and cheeks, a loud "pop" sound was heard followed by a spark and a black soot mark was left on the patient.The soot was wiped away and when the patient returned for follow-up treatment approximately a month later, there was a red circle on the nose that started to scab.

• 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 road; westford, MA 01886 ; 9783940763
• MDR Report Key: 24512809
• Report Number: 3021199089-2026-00012
• Device Sequence Number: 21322081
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)250220
• 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): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/03/2026
• Initial Report FDA Received Date: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female