BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX 1440

    MDR report key: 2568618 · Received May 5, 2012

    Report

    Report Number
    MW5025318
    Event Type
    Malfunction
    Date Received
    May 5, 2012
    Report Date
    May 5, 2012
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FIRM REFUSES TO MAKE AVAILABLE SERVICE INFORMATION PURSUANT TO 21 CFR 1040.10-H--2--II- FOR ANY OF THEIR LASER DEVICES, SPECIFICALLY, LUX 1440, LUX 1540, LUX 2940, LUX 1064, LUX IR, LUX DEEP IR, AND ALL VERSIONS AND/OR REVISIONS THEREOF INCLUDING BUT NOT LIMITED TO THOSE DEVICES REFERRED TO IN 510-K- APPROVAL NUMBERS K090195, K101506, K080244, K073583, K091446, K083900, AND K070298, INCLUDING VERSIONS AND REVISIONS NOT HERE LISTED. ALL OF THESE DEVICES ARE REGISTERED WITH THE FDA AS "POWERED LASER SURGICAL INSTRUMENTS," AND ARE CLASSIFIED BY THE FDA AS "LASER SURGICAL INSTRUMENTS" PURSUANT TO 21 CFR 878.4810, AND ARE CONSIDERED "LIGHT EMITTING PRODUCTS," AND ARE REGULATED BY 21 CFR 1040.10-11, "PERFORMANCE STANDARDS FOR LIGHT EMITTING PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUX 1440 LUX 1440 LASER HAND PIECE GEX PALOMAR MEDICAL TECHNOLOGIES, INC. LUX1440

    Patients

    Seq Age Sex Outcome Treatment
    1