MAUDE Adverse Event Report: CYNOSURE LUTRONIC TECHNOLOGY CORPORATION CLARITY II

Catalog Number	1110200230
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cynosure lutronic (cl) clinical team contacted the site to investigate the event.Cl clinical confirmed that no injury had occurred.A trained cynosure lutronic field service engineer (fse) went to the treatment provider site to perform a device evaluation.Fse performed meter verification in all operative modes.All available windows, fibers, and optics on all cartridges were inspected.Icd operation was verified.Coolant level was checked, and the air filter was cleaned.Burn samples were recorded of all cartridge sizes.Full function test in all operative modes.Device confirmed to be operating within cynosure lutronic published specifications.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.
Event or Problem Description
It was reported that during clarity ii treatment the cryogen was spraying continuously and resolved on its own afterwards.Provider also mentioned that they were not seeing results when performing vascular treatments and laser was not clearing the veins correctly.

• 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, MA 01886
• MDR Report Key: 25306632
• Report Number: 3021199089-2026-00037
• Device Sequence Number: 9422840
• Product Code: GEX
• UDI-Device Identifier: 08800291820040
• UDI-Public: (01)08800291820040(11)241031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: Other
• Device Catalogue Number: 1110200230
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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