MAUDE Adverse Event Report: XTRALLUX, LLC XTRALLUX; HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE

Model Number	XTRALLUX SUPER PLUS
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/26/2025, xtrallux received communication that a device was becoming hot with signs of overheating.
Additional Manufacturer Narrative
The reporter refused to return the device and did not share any images, videos, or other evidence of the alleged event.Xtrallux had requested the device be returned twice, to which the patient refused, and stated that the device was now "working perfectly." the ifu, which was reviewed by the fda through the 510k submission process, states the operating conditions of the device including the temperature range and advises users to keep the device in normal operating conditions for at least 6 hours prior to charging until device is cool to the touch after any extreme conditions during storage or transport.It is unclear if the user had the device in extreme conditions prior to use that may have contributed to the alleged heat.The ifu also advises users, "take care when removing cables from power sources, gently unplugging cables without exerting excess tension on device cables," and encourages, "care should be taken when touching the power pack during charging as the temperature can reach 45.8°c." the ifu also includes instructions that outline the proper steps of ensuring the cables align appropriately by ensuring the cable arrows on both the back of the laser dome and on the power pack align, and advises users to that in the case of a malfunction, to carefully disconnect the device from the electrical source and contact xtrallux.It is unknown due to the lack of information and non-returned device if there was non-approved charging components used, if there was user-inflicted damage to the cable connectors, of if it was a manufacturer defect.The risk is captured in the device's risk assessment and determined to be acceptable.

• Brand Name: XTRALLUX
• Common Device Name: HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE
• Manufacturer (Section D): XTRALLUX, LLC; 7260 nw 58 street; miami FL 33166
• Manufacturer (Section G): XTRALLUX, LLC; 7260 nw 58 street; miami FL 33166
• Manufacturer Contact: frances pina-brea ; 7260 nw 58 street; miami, FL 33166
• MDR Report Key: 23884173
• Report Number: 3025432379-2025-00009
• Device Sequence Number: 18554431
• Product Code: OAP
• UDI-Device Identifier: 00860007783418
• UDI-Public: (01)00860007783418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222364
• 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
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: Lay User/Patient
• Device Model Number: XTRALLUX SUPER PLUS
• Device Lot Number: XSR240300028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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