BEUDAMED
    FDA Recall Terminated

    Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under names including FriendlyLight Er:YAG, LightPod Era, FriendlyLight Nd:YAG, LightPod Neo, LightPod Neo XL, LightPod Neo XT, LightPod Forte, LightPod Allure, and LightPod Nova.

    Recall: Z-1188-2012 · Initiated June 7, 2011

    Recall

    Recall Number
    Z-1188-2012
    Event Number
    61194
    Firm
    Aerolase
    FEI Number
    3004374705
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 7, 2011
    Posted
    March 29, 2012
    Terminated
    June 29, 2018
    Address
    777 Old Saw Mill River Rd, Tarrytown, NY, 10591-6717

    Description

    Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under names including FriendlyLight Er:YAG, LightPod Era, FriendlyLight Nd:YAG, LightPod Neo, LightPod Neo XL, LightPod Neo XT, LightPod Forte, LightPod Allure, and LightPod Nova.

    Reason

    It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers.

    Action

    Aerolase issued a letter to customers, dated 11/30/2011, identifying the affected product and the reason for the recall. Aerolase is providing, at no charge, the Appendix to the Operating Manual for the LightPod lasers. This Appendix describes the procedure and frequency for checking whether the laser is within calibration, but it is not a procedure for customers to actually calibrate the laser themselves; any attempt to do so by any parties other than a company technician employed by Aerolase would void the warranty. Please contact us any time at 914- 345-8300 with any questions.

    Distribution

    Worldwide Distribution

    Quantity

    176