MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Model Number	1110200210
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/18/2026
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 the device was subjected to full functionality testing and visual inspection with passing results.The device was found to be working to published specifications.A member of the cynosure lutronic clinical team made contact with the treatment provider and reviewed the treatment parameters used.It was reported that this was the patient's second treatment and the clinical team determined that the settings used for this treatment were within the recommended range of the quickstart guide (qsg).The icd parameters used were consistent with the updated guidelines.The treatment provider confirmed that the laser tip was maintained perpendicular to the skins surface at all times during treatment without pulse overlapping.The exact treatment date of the first treatment is unknown.This treatment utilized different icd settings that were consistent with the qsg guidelines at that time (10/20/10 ms) and was reported to be well tolerated, with no side effects reported.The clinical team requested updates on the patients healing progress, updated photos, and additional clinical details, however, despite multiple attempts these information requests went unanswered.Based on the information currently available, the cause of the reported side effects from the second treatment cannot be determined.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 a patient experienced a potential laser burn after a spark occurred during laser vascular treatment with a clarity ii device.The patient experienced blistering and the small o-ring tip appears to be burnt.

• 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: 24639285
• Report Number: 3021199089-2026-00016
• Device Sequence Number: 18682038
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)250307
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 03/19/2026

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
• Device Model Number: 1110200210
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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 Sex: Female