MAUDE Adverse Event Report: LUTRONINC CORPORRATION CLARITY II

Catalog Number	1110200230
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that spark and soot occurred during a laser hair removal treatment on the face using clarity ii.No patient injury was reported.
Additional Manufacturer Narrative
Cynosure lutronic clinical team contacted the site to investigate the event.Cynosure lutronic clinical determined the event to be inconclusive.Site failed to respond to multiple contact attempts and therefore additional details could not be obtained.A trained cynosure lutronic field service engineer (fse) went to the site to perform a device evaluation.Cartridges 22, 18, and 15 lens were spotted and damaged.Window on handpiece was spotted and needed replacement.The small o-type tip that was used for treatment was damaged with a small burn spot.Target output was 45.62j but actual output was 41.07j.Fse suspect energy loss from lens degradation.Energy outputs for 1064nm and 755 nm were all within specification.Fse ordered replacements for damaged lens, handpiece, and o-type tip.Spark that occurred is likely related to the cryogen involved.Cryogen is applied to the treatment site during vascular treatment to precool the skin.The cryogen begins to vaporize from the surface of the skin shortly after contact.The laser fires onto the surface of the skin after a delay time.The spark/ignition events occur when residual cryogen vapors remaining on the skin surface interact with the high-energy 1064 nm laser fluence.Longer pre-cooling and delay times increase the likelihood of uneven vapor accumulation, thereby elevating the risk of ignition.This can be observed as a spark and can result in topical burn.To reduce the probability of reoccurrence the treatment provider was informed that vascular lesion treatments over 60 j/cm2 should utilize an icd setting of 10/10/10 per the recent update.A customer letter has since gone out to notify customers of this recommended setting update.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): LUTRONINC CORPORRATION; lutronic center; 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: 25242442
• Report Number: 3021199089-2026-00032
• Device Sequence Number: 21263758
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)250416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/21/2026

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: 04/23/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Female