MAUDE Adverse Event Report: Xtrallux, LLC Xtrallux; Hair Regrowth Cap - Photobiomodulating Device

Model Number	Xtrallux Extreme Rx
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• 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: 50794648
• Report Number: 3025432379-2026-00004
• Device Sequence Number: 10515984
• Product Code: OAP
• UDI-Device Identifier: 00860007783449
• UDI-Public: (01)00860007783449
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K222364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: Lay User/Patient
• Device Model Number: Xtrallux Extreme Rx
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Female