BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRALLUX

    MDR report key: 22806162 · Received August 14, 2025

    Report

    Report Number
    3025432379-2025-00004
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Report Date
    November 26, 2025
    Manufacturer
    XTRALLUX, LLC
    Product Code
    OAP
    PMA / PMN Number
    K222364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    XTRALLUX RECEIVED THE SUBJECT DEVICE ON 10/28/2025 AND INSPECTED THE DEVICE. THE IFU STATES ON PAGE 5 THAT THE POWER PACK CAN REACH TEMPERATURES OF 45.8 DEGREES CENTIGRADE (114.44 DEGREES FAHRENHEIT), AND THAT CARE SHOULD BE TAKEN WHEN CHARGING. THE TEMPERATURES OBSERVED DURING INSPECTION WERE WITHIN THE SPECIFICATION. IT WAS ALSO OBSERVED THAT THERE WAS DAMAGE TO THE PIN RECEPTACLES ON LASER DOME CABLE CONNECTOR AND POWER PACK CABLE CONNECTION WHICH CAUSES AN UNSTABLE CONNECTION BETWEEN LASER DOME AND POWER PACK. DUE TO THIS DAMAGE, THE CABLES NEED TO BE HELD TOGETHER TO KEEP THE DEVICE OPERATING AND THE TEMPERATURE AT THAT CONNECTION GETS WARM. THE LASER DOME WAS TESTED WITH A REPLACEMENT POWER PACK AND WORKED NORMALLY. THE DAMAGED LASER DOME WAS SERVICED AND THE POWER PACK WAS REPLACED BEFORE RETURNING TO THE CUSTOMER. THE DEVICE'S IFU 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". IT CAN BE RESONABLY ASSUMED THE DAMAGE INFLICTED CAUSING THE DEVICE TO WARM IS ATTRIBUTED TO THE USER.

    Additional Manufacturer Narrative · 0

    UPON BECOMING AWARE OF THE EVENT, XTRALLUX REQUESTED THAT THE DEVICE BE RETURNED FOR INVESTIGATION. AFTER THREE ATTEMPTS TO CONTACT THE CUSTOMER, NO ADDITIONAL INFORMATION WAS PROVIDED AND THE DEVICE WAS NOT RETURNED. IN THE ABSENCE OF THE DEVICE, THE INVESTIGATION WAS CONDUCTED USING INDIRECT METHODS, INCLUDING BATCH RECORD REVIEW AND TREND ANALYSIS. NO FINDINGS WERE IDENTIFIED. THE DEVICE'S INSTRUCTIONS FOR USE (IFU), REVIEWED BY THE FDA AS PART OF THE 510(K) SUBMISSIONS, SPECIFY OPERATIONAL CONDITIONS, INCLUDING RECOMMENDED TEMPERATURE RANGE, AND INSTRUCT USERS TO ALLOW THE DEVICE TO RETURN TO NORMAL OPERATING CONDITIONS FOR AT LEAST 6 HOURS PRIOR TO CHARGING IF EXPOSED TO EXTREME STORAGE OR TRANSPORT CONDITIONS. THE IFU ALSO PROVIDES SETUP, POWER PACK CHARGING, AND OPERATIONAL INSTRUCTIONS. BECAUSE COMPONENT USAGE COULD NOT BE CONFIRMED, IT IS UNKNOWN WHETHER XTRALLUX-SUPPLIED CHARGING CABLES AND POWER PACKS WERE USED. USE OF NON-APPROVED CHARGING COMPONENTS MAY RESULT IN IMPROPER CHARGING PERFORMANCE, INCLUDING THE POTENTIAL FOR HEAT GENERATION. THE IFU INSTRUCTS USERS THAT IN THE EVENT OF A MALFUNCTION, THE DEVICE SHOULD BE DISCONNECTED FROM THE ELECTRICAL SOURCE AND TO CONTACT XTRALLUX. THE POTENTIAL HAZARD OF EXCESSIVE HEAT GENERATION IS ADDRESSED IN THE DEVICE'S RISK ASSESSMENT, AND ASSOCIATED RISKS WERE DETERMINED TO BE WITHIN ACCEPTABLE LIMITS.

    Description of Event or Problem · 0

    ON 10/28/2025, XTRALLUX RECEIVED THE SUBJECT DEVICE AND WAS ABLE TO INSPECT THE PRODUCT.

    Description of Event or Problem · 0

    ON 07/16/2025, XTRALLUX RECEIVED COMMUNICATION FROM A PATIENT CLAIMING THAT THE CONNECTION BETWEEN THE CAP AND THE BATTERY WAS GETTING EXCESSIVELY HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686438 XTRALLUX HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE OAP XTRALLUX, LLC XTRALLUX TURBO PRO XTRA154-120123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown