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Laser Energetics Inc. Message Board

  • robert.vince robert.vince Feb 19, 2013 9:44 AM Flag

    Laser Energetics Announces the Dazer Laser(R) GUARDIAN Is Compliant With FDA Safety Regulations

    MERCERVILLE, NJ--(Marketwire - Feb 19, 2013) - Laser Energetics, Inc. ( PINKSHEETS : LNGT ) today reported that its Dazer Laser® GUARDIAN is fully compliant with the FDA's Center for Devices and Radiological Health (CDRH) - 21 CFR 1040.10 standard for laser products. The GUARDIAN is the first of the Dazer Laser® Product Line to be in compliance with this important FDA requirement. The FDA 21 CFR 1040.10 standard sets the performance and labeling requirements that all laser products must meet prior to shipment for commercial and government entities throughout the United States.

    The Company recently retained Jerome Dennis to assist the Company in bringing the Dazer Laser® Products into full compliance with the requirements of the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA). Mr. Dennis retired with more than three decades of experience within that agency, where he served as the International Expert in Lasers and Optical Radiation Safety and Safety Standards. He has had the highest leadership roles such as the Chairman of the International Electrotechnical Commission Technical Committee 76 on optical radiation safety and laser products and as Past Vice Chairman of the ANSI Z136 standards committee.

    Mr. Dennis stated, "The Laser Energetics Dazer Laser® GUARDIAN is now compliant with the FDA 21 CFR 1040.10 performance standard for lasers and laser products. In working with the Company through the GUARDIAN's successful compliance to the FDA and US Government Regulations, the first of the Dazer Laser® Products, I found that the GUARDIAN required very minimal changes which ensured compliance with the standard, making this a very short and smooth process."

    Robert D. Battis, Founder, President & CEO of Laser Energetics, Inc., stated, "The GUARDIAN's successful compliance to the critically important FDA 21 CFR 1040 standard is extremely exciting news that provides significant credibility and acceptance of our GUARDIAN system to the US Military, Commercial and Foreign marketplace. Compliance now removes the limits on sales for Test & Evaluation orders and provides the Company the ability to deliver unlimited order sizes to Law Enforcement Agencies and the US Federal Government. On behalf of Laser Energetics, I would like to thank our loyal shareholders for their continued support as we continue to break through the Optical Distractor markets with our Dazer Laser® Products. Successful FDA Compliance solidifies our rapidly expanding position throughout the World."