BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNDO PMU PICO LASER

    MDR report key: 25136859 · Received May 11, 2026

    Report

    Report Number
    MW5187906
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 5, 2026
    Manufacturer
    UNDO PMU WORLDWIDE LASERS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS BURNED BY THIS UNLICENSED DEVICE: HTTPS://UNDO-PMU.COM/PAGES/SUPPLIES. THEY SAY ITS REGISTERED BUT THEY DO NOT HAVE A PRIVATE LICENSE? I CAN'T FIND ANYTHING ABOUT THIS MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533567 UNDO PMU PICO LASER POWERED LASER SURGICAL INSTRUMENT GEX UNDO PMU WORLDWIDE LASERS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Hospitalization