BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRALLUX

    MDR report key: 22515827 · Received July 15, 2025

    Report

    Report Number
    3025432379-2025-00003
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Report Date
    July 15, 2025
    Manufacturer
    XTRALLUX, LLC
    Product Code
    OAP
    PMA / PMN Number
    K222364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER INFORMED XTRALLUX THAT THE DEVICE HAD BEEN PERFORMING NORMALLY, BUT DURING THE USER'S LAST USE THE DEVICE HAD GENERATED EXCESSIVE HEAT AND GAVE THE USER A HEADACHE. UPON BECOMING AWARE OF THE EVENT, XTRALLUX REQUESTED THE DEVICE BE RETURNED FOR INVESTIGATION. THE SUBJECT DEVICE WAS RETURNED ON 06/09/2025 AND INVESTIGATED ON 07/11/2025. THE INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED EVENT, AS BOTH THE LASER DOME AND POWER PACK WERE TESTED AND FOUND THAT THE INTERIOR, PATIENT-CONTACTING SURFACES DID NOT EXCEED THE DEVICE'S TEMPERATURE SPECIFICATION. THE OUTPUT POWER OF THE DEVICE WAS CONSISTENT AND UNDER 5MW IN ACCORDANCE WITH FDA CLASS 3R LASERS. THE DEVICE WAS CONFIRMED TO MEET SPECIFICATION. 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 HEAT. THE IFU ALSO INSTRUCTS USERS THAT IN THE EVENT OF A MALFUNCTION TO DISCONNECT THE DEVICE FROM THE ELECTRICAL SOURCE AND CONTACT XTRALLUX. ADDITIONALLY, IT ADVISES USERS TO IMMEDIATELY DISCONTINUE USE IF EXPERIENCING ANY DISCOMFORT DURING OR AFTER TREATMENT AND ENCOURAGES USERS TO CONTACT THEIR PHYSICIAN. THE POSSIBLE SCENARIO OF THE DEVICE MALFUNCTIONING AND GENERATING TOO MUCH HEAT IS CAPTURED IN THE RISK ASSESSMENT AND THE RISKS WERE DETERMINED TO BE ACCEPTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, XTRALLUX RECEIVED COMMUNICATION FROM A PATIENT CLAIMING THAT WHEN USING THEIR DEVICE, IT HAD GENERATED EXCESSIVE HEAT AND GAVE THEM A HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601319 XTRALLUX HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE OAP XTRALLUX, LLC XTRALLUX ALPHA XTRA175-090524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown