BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRALLUX

    MDR report key: 23835002 · Received December 17, 2025

    Report

    Report Number
    3025432379-2025-00008
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 17, 2025
    Manufacturer
    XTRALLUX, LLC
    Product Code
    OAP
    UDI-DI
    0086007783449
    PMA / PMN Number
    K222364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION AND THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED DUE TO THE DAMAGE UPON ARRIVAL. THERE WAS PHYSICAL DAMAGE TO CABLE CONNECTIONS, AND THE DAMAGED PINS AND PIN RECEPTACLE SHOWED SIGNS OF FORCE USED TO CONNECT MISALIGNED CABLES. THE DEVICE WOULD NOT OPERATE AS IS, AND THUS, WAS UNABLE TO BE TESTED, WHICH IS WHY CODE 4117 FOR BLOCK H(6)(B) WAS SELECTED. WITHIN THE DEVICE'S IFU, WHICH WAS REVIEWED BY THE FDA THROUGH THE 510(K) REVIEW PROCESS, IT STATES "TAKE CARE WHEN REMOVING CABLES FROM POWER SOURCES, GENTLY UNPLUGGING CABLES WITHOUT EXERTING EXCESS TENSION ON DEVICE CABLES," AND ENCOURAGES USERS, "CARE SHOULD BE TAKEN WHEN TOUCHING THE POWER PACK DURING CHARGING AS THE TEMPERATURE CAN REACH 45.8°C." THE IFU ALSO INCLUDES OPERATING 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. IT ALSO ADVISES USERS THAT IN THE CASE OF A MALFUNCTION TO CAREFULLY DISCONNECT THE DEVICE FROM THE ELECTRICAL SOURCE AND CONTACT XTRALLUX. THE ROOT CAUSE IS ATTRIBUTED TO PHYSICAL DAMAGE TO THE CABLE CONNECTORS, WHICH IS PRESUMED TO BE DUE TO IMPROPER USE/USER INFLICTED DAMAGE. THE DEVICE'S RISK ASSESSMENT CAPTURES THE RELATIVE RISK AND HAS DETERMINED IT TO BE ACCEPTABLE.

    Description of Event or Problem · 0

    ON 11/17/2025, XTRALLUX RECEIVED COMMUNICATION THAT A DEVICE'S CHARGING CABLE/CONNECTER REPORTEDLY MELTED AND WAS NO LONGER FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273931 XTRALLUX HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE OAP XTRALLUX, LLC XTRALLUX EXTREME RX XERX240400002 0086007783449

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown