MAUDE Adverse Event Report: LUTRONIC CORPORATION DERMAV

Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a dermav device sparked, made a loud popping sound and left a black soot mark on the patient.It was confirmed that there was no patient injury.
Additional Manufacturer Narrative
A trained cynosure lutronic field service engineer (fse) went to the treatment provider site for device evaluation.While on site, the system was in use during a treatment session by the provider.The fse was present while the treatment was being performed.During the treatment the fse observed the device make a loud pop, spark and leave a black soot mark on the patient.The black soot was wiped away and there was no visible burn or injury present.Following this observation, the device was subjected to multiple tests by the fse including: full functionality check, energy testing, and cryogen testing all with passing results.The distance gauge and intellitrak were visually inspected for any evidence of burn marks or other damage with no discrepancies observed.The device was found to be operating within published specifications.It is unknown what caused the reported issue.A member of the cynosure lutronic clinical team made contact with the treatment provider and determined that the treatment parameters used were 1064 nm, 14 mm, 5 ms, 26 j, 1 htz,icd 20/20/0 and are within the recommended published clinical guidelines for hair removal treatment.It is undetermined what caused the reported spark, pop and black soot on the patients skin.The event is reportable per fda medical device reporting title 21 cfr part 803 since a malfunctioned occurred and would likely cause or contribute to a serious injury if the malfunction were to recur.

• Brand Name: DERMAV
• Common Device Name: DERMAV
• 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 road; westford, MA 01886 ; 9783940763
• MDR Report Key: 24471459
• Report Number: 3021199089-2026-00010
• Device Sequence Number: 18481861
• Product Code: GEX
• UDI-Device Identifier: 08809447655277
• UDI-Public: (01)08809447655277(11)250718
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K203788
• 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): 02/27/2026

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?: No
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• 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