MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A trained cynosure lutronic field service engineer (fse) went to the customer site for a device evaluation.During this time, the reported issue was observed.The nozzle inside the handpiece was found to be loose and was tightened to correct the issue.It is undetermined how this nozzle became loose.After the nozzle was tightened, the device pressure was tested with passing results.A member of the cynosure lutronic clinical was originally told by the treatment site that the patient (who was reported to be a staff member) "had a blister on the treatment area but is fine".Additional contact attempts to the treatment site were made to obtain information about how the patient was healing as well as requesting additional photos of healing, however, these information requests went unanswered.Images of the blister were not provided for evaluation.The event is reportable per fda medical device reporting title 21 cfr part 803 since a malfunction 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 training on (b)(6) 2026, cryogen started spilling from the handpiece resulting in a raised red patch on the leg.

• 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: 24389667
• Report Number: 3021199089-2026-00008
• Device Sequence Number: 13417466
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: 08809447653723
• Combination Product (Y/N): Y
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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