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	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/03/2025, xtrallux received communication from a patient claiming that the device was getting hot on the patient's head.
Additional Manufacturer Narrative
The subject device was returned for investigation and the reported issue was unable to be replicated.However, there was user-inflicted damage to the laser dome cable and receptacle.The ifu, which was reviewed by the fda through the 510k submission process, states the operation 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 reported event.The ifu also provides setup, power pack charging, and operational instructions.The user was referred to the ifu to follow storage and operational temperatures in case this contributed to the alleged heat generation.The ifu also instructs users that in the event of a malfunction to disconnect the device from the electrical source and contact xtrallux.The device's risk assessment captures the relative risk and has determined it 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: 23711964
• Report Number: 3025432379-2025-00007
• Device Sequence Number: 10401505
• Product Code: OAP
• UDI-Device Identifier: 00860007783418
• UDI-Public: (01)00860007783418
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 12/03/2025

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: XSR231200055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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