MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF 2.0

Model Number	1101300330
Medical Device Problem Codes	Defective Component (2292); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient experienced skin burning and scabbing after xerf treatment on the face.
Additional Manufacturer Narrative
A member of the cynosure lutronic clinical team reviewed the treatment parameters used and confirmed that they were within the normal approved clinical range.The patient reported that the burning and scabbing was experienced two days post treatment and lasted for seven days.It was reported that the patient has fully recovered.Review of the images provided of the device tip did observe a small burn mark on the effector surface.The tip has been returned to the manufacturer for further evaluation.At this time, it is unknown what contributed to the reported malfunction and burning observed damage to the tip observed in the provided image.It is unknown what caused this observed defect to the tip.The defect was observed but unable to be verified if it contributed to the reported burning.A final mdr will be submitted once investigation has been completed.Since a reported malfunction and potential for serious injury occurred, we are reporting this as an initial mdr.

• Brand Name: XERF 2.0
• Common Device Name: XERF 2.0
• 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 rd; westford, MA 01886
• MDR Report Key: 23933926
• Report Number: 3021199089-2025-00027
• Device Sequence Number: 5626014
• Product Code: GEI
• UDI-Device Identifier: 08809447657981
• UDI-Public: (01)08809447657981(11)251015
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K180945
• 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,Followup
• Report Date (Section B): 06/26/2026

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 Model Number: 1101300330
• Device Catalogue Number: 1101300310
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 06/26/2026
• 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: Female