MAUDE Adverse Event Report: CYNOSURE LUTRONIC TECHNOLOGY CORPORATION CLARITY II

Catalog Number	1110200210
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A member of the cynosure lutronic technology (clt) clinical team contacted the treatment site for additional information.During treatment the patient did not report any pain, heat or burning sensation.Other angiomas in the area were treated without incident.During treatment it was reported there was a spark seen and black soot was observed on the patient's skin, the soot was cleaned away with cold water.The site reported that the icd settings used were 10/20/10, which may have contributed to the reported spark and patient burn.Per current clinical treatment guidelines in the quickstart guide (qsg), it is recommended for vascular or angioma treatment that the icd settings be set to 10/10/10.Additionally, review of the treatment parameters used observed that the fluence used was higher than the recommended published parameters of the qsg.It is unknown if the high fluence contributed to the reported issue.The medical director reviewed the images provided by the treatment site of the patients burn.These images were reviewed by the clt medical director who determined that the burn was not at risk for permanent impairment or infection.To reduce the probability of reoccurrence, the clinical team reviewed with the treatment clinic that the icd setting is 10/10/10 for this treatment.A new w qsg has been provided to the site with appropriate fluence settings and virtual training has been dispatched to the site to review the appropriate treatment parameters and cryogen settings.This event is reportable under fda medical device reporting requirements (21 cfr part 803), as it involves a device malfunction that could potentially cause or contribute to a serious injury if the issue were to recur.
Event or Problem Description
It was reported that a patient experienced a burn post angioma treatment on the abdomen with a clarity ii device.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 219 sowon-ro; deogyang-gu, goyang-si 10534 ,; KS 10534,
• Manufacturer (Section G): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford
• MDR Report Key: 25472940
• Report Number: 3021199089-2026-00041
• Device Sequence Number: 13378617
• Product Code: GEX
• UDI-Device Identifier: 08800291820040
• UDI-Public: (01)08800291820040(11)251202
• 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: Foreign,Consumer,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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 Catalogue Number: 1110200210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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