MAUDE Adverse Event Report: CYNOSURE LUTRONIC TECHNOLOGY CORPORATION CLARITY II

Model Number	1110200210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	05/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 cynosure lutronic became aware of a clarity ii sparking during treatment.Treatment clinic relayed seeing a spark and hearing it.This occurred with three patients during separate treatments using icd 10/10/10 settings.One out of three of the patients experienced a blister post treatment.It was noted that the device is eco-friendly; however, the treatment clinic reported that they may have been using a cryogen canister with a red lid, which contains a non-environmentally friendly cryogen.A member of the cynosure lutronic clinical team contacted the treatment clinic on (b)(6) 2026 and confirmed that the treatment parameters used were within the recommended clinical guidelines of the quickstart guide (qsg).This was the patient's second reported treatment; the first treatment was performed on (b)(6) 2026 with treatment parameters used also to be within recommended clinical limits.A test spot was reportedly taken prior to the start of treatment and the treatment clinic reported cleansing the patient's skin before treatment with 70% isopropyl alcohol.The treatment clinic reported that the patient did not have any recent sun exposure that would affect the treatment.There were no images of the patient pre, or post treatment supplied despite multiple attempts to obtain images for the cynosure lutronic medical director could review.It was noted that the site reported they may have been using a cryogen canister with the "red lid".This is an old non-eco-friendly cryogen material; it is undetermined if this contributed to the reported sparking or reported patient side effects.On 23 june 2026 a trained cl field service engineer (fse) went to the site to perform a device evaluation.Fse performed a system evaluation and functional check.Handpiece and fiber were then inspected.Fse checked the energy on both alex and yag using 18mm.Fse also inspected and tested 3mm/5mm, 8mm/10mm/12mm cartridges on customer's reported fluence setting.Fse confirms no issues were found and laser energy was within specification.Root cause to how the device sparked is inconclusive since the device was found to be operating within specification and no other treatment information was made available.The event is reportable per fda medical device reporting title 21 cfr part 803 since an observed malfunction occurred and could likely cause or contribute to a serious injury if the malfunction were to recur.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 55 samwon-ro; deogyang, goyang gyeonggi ; KS
• MDR Report Key: 25635262
• Report Number: 1222993-2026-00061
• Device Sequence Number: 9735818
• Product Code: GEX
• UDI-Device Identifier: 08800291820040
• UDI-Public: (01)08800291820040(11)250418
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026
• Report Date (Section F): 06/26/2026

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2026