BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRALLUX

    MDR report key: 23884173 · Received December 23, 2025

    Report

    Report Number
    3025432379-2025-00009
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 23, 2025
    Manufacturer
    XTRALLUX, LLC
    Product Code
    OAP
    UDI-DI
    00860007783418
    PMA / PMN Number
    K222364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER REFUSED TO RETURN THE DEVICE AND DID NOT SHARE ANY IMAGES, VIDEOS, OR OTHER EVIDENCE OF THE ALLEGED EVENT. XTRALLUX HAD REQUESTED THE DEVICE BE RETURNED TWICE, TO WHICH THE PATIENT REFUSED, AND STATED THAT THE DEVICE WAS NOW "WORKING PERFECTLY." THE IFU, WHICH WAS REVIEWED BY THE FDA THROUGH THE 510K SUBMISSION PROCESS, STATES THE OPERATING 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 ALLEGED HEAT. THE IFU ALSO ADVISES USERS, "TAKE CARE WHEN REMOVING CABLES FROM POWER SOURCES, GENTLY UNPLUGGING CABLES WITHOUT EXERTING EXCESS TENSION ON DEVICE CABLES," AND ENCOURAGES, "CARE SHOULD BE TAKEN WHEN TOUCHING THE POWER PACK DURING CHARGING AS THE TEMPERATURE CAN REACH 45.8°C." THE IFU ALSO INCLUDES 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, AND ADVISES USERS TO THAT IN THE CASE OF A MALFUNCTION, TO CAREFULLY DISCONNECT THE DEVICE FROM THE ELECTRICAL SOURCE AND CONTACT XTRALLUX. IT IS UNKNOWN DUE TO THE LACK OF INFORMATION AND NON-RETURNED DEVICE IF THERE WAS NON-APPROVED CHARGING COMPONENTS USED, IF THERE WAS USER-INFLICTED DAMAGE TO THE CABLE CONNECTORS, OF IF IT WAS A MANUFACTURER DEFECT. THE RISK IS CAPTURED IN THE DEVICE'S RISK ASSESSMENT AND DETERMINED TO BE ACCEPTABLE.

    Description of Event or Problem · 0

    ON 11/26/2025, XTRALLUX RECEIVED COMMUNICATION THAT A DEVICE WAS BECOMING HOT WITH SIGNS OF OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517601 XTRALLUX HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE OAP XTRALLUX, LLC XTRALLUX SUPER PLUS XSR240300028 00860007783418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown