FDA warning letter.SALT LAKE CITY--(BUSINESS WIRE)--June 26, 1996--Lynn B. Barney, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Ion Laser Technology (AMEX AMEX See: American Stock Exchange :ILT ILT infectious laryngotracheitis. ), issued the following statement regarding the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Warning Letter received by the company and reported over the Dow Jones Wire Service: "The company received a warning letter from the FDA late afternoon of June 19, 1996. A task force was established the same day to assess the merits of the issues raised by the FDA and determine a plan to deal with those issues will be submitted to the FDA during the week of July 1, 1996, within the required time frame. "It is important that we clarify the issues for our investors," stated Barney, "and the following facts should be understood: 1. The products addressed in the letter, the Genesis 2000 carbon dioxide laser The carbon dioxide laser (CO2 laser) was one of the earliest gas lasers to be developed (invented by Kumar Patel of Bell Labs in 1964[1]), and is still one of the most useful. , the ACL See access control list. 1. ACL - Access Control List. 2. ACL - Association for Computational Linguistics. 3. ACL - A Coroutine Language. A Pascal-based implementation of coroutines. ["Coroutines", C.D. 5500 argon air-cooled laser, and the ACL-5500 argon water cooled laser, received FDA Market Clearance on April 10, 1992, April 23, 1993, and March 24, 1995, respectively. The products have not been changed since the marketing clearance dates. 2. The letter addressed two areas of product labeling noncompliance noncompliance failure of the owner to follow instructions, particularly in administering medication as prescribed; a cause of a less than expected response to treatment. noncompliance and requested information in two additional areas. Both noncompliance issues require at a minimum changes to the operator's manuals for the laser devices. 3. Failure to file one annual report in 1995 was merely an oversight which has now been corrected. Previous reports have been submitted. 4. The statement in the Dow Jones release that the Company's products do not have safety interlocks is incorrect. The FDA requests clarification as to whether the Company's products comply with the safety interlock A device that prohibits an action from taking place. requirements of the FDA. The issue is a labeling issue for the interlocks that exist in all of the Company's dental laser products and the FDA has requested additional information only. 5. The final item in the letter states: "We recommend that your warning logo-type labels include the laser wavelength, in order for the users to easily select the correct protective eye wear." The Company provides proper protective eye wear with each laser system. In the opinion of the Company, the issues are related to text requirements of operator's manuals for the laser devices and do not concern the safety or effectiveness of the lasers. The issues will be completed within two weeks at an estimated cost of less than $10,000. We do not expect this event to change our annual objectives for the establishment of tooth whitening locations." CONTACT: Ion Laser Technology Kimberli Gubler, 801/262-5555 |
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