MAUDE Adverse Event Report: LUTRONIC CORPORATION DERMAV

Catalog Number	R1011600300
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a vascular treatment on the leg a bright pulse was observed with a dermav laser device.Soot was noted on the patient's skin immediately following the pulse, however, there was no patient injury reported.
Additional Manufacturer Narrative
A trained cynosure lutronic field service engineer went to the treatment clinic for a device evaluation.During this time the device was subjected to a full device evaluation including full functionality testing with passing results.Visual inspection observed spots on some of the handpiece lenes, however, it is not believed that this is related to the reported bright pulsing observed during treatment.The cryogen settings were checked and during this time it was observed that these settings were set for the 360a cryogen cans, however, the device was loaded with the 360b cryogen.It is undetermined if this contributed to the reported issue, but as a precaution the settings were adjusted to the 360b cryogen settings based on the cryogen being used at the treatment clinic.A member of the cynosure lutronic clinical team followed up with the treatment provider and confirmed that there were no patient injuries.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.

• 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
• MDR Report Key: 25122843
• Report Number: 3021199089-2026-00026
• Device Sequence Number: 21506483
• Product Code: GEX
• UDI-Device Identifier: 08809447655277
• UDI-Public: (01)08809447655277(11)211124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/08/2026

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: R1011600300
• 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: 04/08/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (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