MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Model Number	1110200210
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A trained cynosure lutronic field service engineer went to the treatment provider site for a device evaluation.During this time, the fse did not observe the device sparking, however, testing found the device was not working to the published specifications.The spot sizes 18 and 25 were visually inspected and observed some damage.It is undetermined what caused this damage, or if it contributed to the reported sparking but to correct the observation, replacement spot sizes were ordered.A member of the cynosure lutronic clinical team made contact with the treatment provider and confirmed that there was no patient injuries.The treatment provider reported that they replaced the hp window and the sparking did not occur again.The treatment provider reported that the window was damaged, however, there was no image of the window nor was it was returned for further evaluation.Therefore, it is undetermined if any damage or possible particulate on the window contributed to the reported sparking.To reduce the probability of reoccurrence, the cleaning and maintenance protocols were provided to the treatment site.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 treatment sparks were coming out of the tip of the clarity ii handpiece (hp).There was no patient injury reported.

• 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: 24594004
• Report Number: 3021199089-2026-00015
• Device Sequence Number: 13351010
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)250703
• 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): 03/13/2026

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: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• 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 Sex: Unknown