BEUDAMED
    FDA Recall Terminated

    LightPod ERA lasers

    Recall: Z-0768-2020 · Initiated August 1, 2019

    Recall

    Recall Number
    Z-0768-2020
    Event Number
    84568
    Firm
    Aerolase Corporation
    FEI Number
    3004374705
    Product Code
    GEX
    Status
    Terminated
    Initiated
    August 1, 2019
    Terminated
    March 30, 2021
    Address
    777 Old Saw Mill River Rd, Ste 205, Tarrytown, NY, 10591-6703

    Description

    LightPod ERA lasers

    Reason

    This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device

    Action

    Aerolase notified all customers to whom such product was delivered. Customer will be informed that the firm plan to provide immediately, and without charge, a remote interlock connector for use with their Aerolase lasers. For questions contact Aerolase in Tarrytown, NY at [email protected] or 914-345-8300.

    Distribution

    US Nationwide Distribution

    Quantity

    65