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Laser Energetics Inc. Message Board

  • smittersmitter smittersmitter Aug 15, 2013 2:15 PM Flag

    What all the Hub-Bub is about... word for word

    Founders Message #13
    August 13, 2013
    To the Shareholders & Friends of Laser Energetics:
    The team at Laser Energetics has been pressing very hard in developing the marketplace for the Dazer Laser® – Light Fighting Technologies product line. In February 2013, the Company announced that it’s Dazer Laser® GUARDIAN was compliant with FDA regulations. Additionally, LEI applied for a Variance from the FDA’s compliance which would not make us add an unnecessary and costly switch to the Dazer Laser® GUARDIAN. In May of 2013, the FDA turned down the Variance, having nothing to do with compliance, which they placed on their website in July. Unknown to the public, LEI had already challenged the FDA on this decision with the advice and guidance from our consultant who spent more than three decades with the FDA on this subject matter. The following is a summary of LEI’s current status with the FDA, as well as the recent legal proceedings and patent issuance:
    Dazer Laser® GUARDIAN and FDA 21 CFR Compliance and Variance:
    Laser Energetics, with the advice and expertise of Mr. Jerome Dennis, who, until his retirement after 32 years of service with the FDA in 2008, was the CDRH’s international expert in laser radiation safety standards, recently announced that the Dazer Laser® GUARDIAN was compliant with the FDA’s 21 CFR regulations for laser products. Mr. Dennis states that LEI is right in that the Dazer Laser® GUARDIAN is in full compliance with the FDA standard and may be sold to law enforcement agencies and commercial entities. In order to be in full compliance, the FDA standard requires the products to be provided with an electrical connector that permits the operator of the product to connect a remote door interlock switch or other emergency stop switch. Now, being that our customer base would never want to use this remote door interlock switch in the tactical use of the Dazer Laser® GUARDIAN, we took the next steps with the FDA to apply for a Variance to remove this switch. Asi

    Sentiment: Strong Buy

 
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