BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRALLUX

    MDR report key: 23711964 · Received December 3, 2025

    Report

    Report Number
    3025432379-2025-00007
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    XTRALLUX, LLC
    Product Code
    OAP
    UDI-DI
    00860007783418
    PMA / PMN Number
    K222364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ON 11/03/2025, XTRALLUX RECEIVED COMMUNICATION FROM A PATIENT CLAIMING THAT THE DEVICE WAS GETTING HOT ON THE PATIENT'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744653 XTRALLUX HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE OAP XTRALLUX, LLC XTRALLUX SUPER PLUS XSR231200055 00860007783418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown