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

Model Number	XTRALLUX TURBO PRO
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/06/2026, xtrallux received communication that while a user was cleaning their device, they claimed there was a burn in the plastic cover.
Additional Manufacturer Narrative
The device was returned on 01/09/2026, and upon receipt of the device and visual inspection, there was evidence of extensive physical damage to both the laser dome shell and board assembly.The damage observed on the device could present an electrical safety hazard and the user was informed that the device is no longer safe to operate in its current condition.There were no signs of a "burn" as reported, thus the complaint was unconfirmed.The root cause is user damage.Within the device's ifu, which was reviewed by the fda through the 510(k) review process, states "care should be taken to protect the integrity of the device.It is recommended to keep your xtrallux device in its protective storage case between uses to prevent accidental damage and avoid excess wear and tear.Take care when removing cables from power sources, gently unplugging cables without exerting excess tension on device cables".The ifu also warns users to not operate the device if any components are damaged, and to not exert excessive force as it can cause damage.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: 24270427
• Report Number: 3025432379-2026-00001
• Device Sequence Number: 21500243
• Product Code: OAP
• UDI-Device Identifier: 00860007783432
• UDI-Public: (01)00860007783432
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/05/2026

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 TURBO PRO
• Device Lot Number: XTR231100011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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