LaserSight announces CE Mark certification.ST. LOUIS--(BUSINESS WIRE)--Dec. 20, 1996--LaserSight Incorporated (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :LASE) is pleased to announce its wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , LaserSight Technologies, Inc., is now certified to apply the CE Mark to its LaserScan 2000 excimer laser A gas laser in which a very short electrical pulse excites a mixture containing a halogen such as fluorine and a rare gas such as argon or krypton. It produces a brief, intense pulse of ultraviolet light. . CE Mark is the quality assurance certification requirement recognized by members of the European community for sales into those countries. Fulfillment of CE Mark requirements allows LaserSight to expand European sales efforts of its LaserScan 2000 excimer laser into the countries of Germany, France, Switzerland, and Austria. "LaserSight has been actively marketing in Europe in anticipation of CE Mark certification," said William Kern, interim president of LaserSight Technologies, Inc. "This certification allows us to strongly position our laser in Europe well in advance of 1998 when all European community countries will require CE Mark certification for sales." LaserSight also announced its has retained De Ceunynck of Belgium as its distributor for Benelux (Belgium, Holland, and Luxembourg). De Ceunynck is the oldest ophthalmic company in the region and boasts an excellent reputation for service standards. De Ceunynck formerly distributed Meditek lasers, but has recognized the demand for the scanning technology of LaserSight's LaserScan 2000. "Holland alone has a population of 15 million people and only four installed lasers. The international demand for the excimer laser remains strong and many countries have a limited installation base, or none at all. We are now represented by 20 distributors and have laser installations in 29 countries worldwide. We are continuing to build our distributor base as LaserSight's LaserScan 2000 is very well recognized internationally," said Paul R. Barros, vice president of sales and marketing for LaserSight. CE Mark has been made possible by receipt of the Certificate of Conformity under Annex III according to the European Medical Devices Directive You can improve this article by adding links to related material, within the existing text. After links have been created, remove this message. For more information, see the . (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9002 and EN 46002 Quality Management Systems and Annex V of the European Medical Devices Directive (93/42/EEC) by SEMKO SEMKO Svenska Elektriska Materielkontrollanstaiten (Sweden) which is a requirement for CE Mark. SEMKO is accredited accredited recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria. accredited herds cattle herds which have achieved a low level of reactors to, e.g. by SWEDAC SWEDAC Swedish Board for Technical Accreditation and is recognized as the foremost notified body in Europe. Certification to ISO 9002 has also been approved by their well known U.S. based affiliate, Intertek, who is accredited by the Dutch Council (RvA). These approvals apply to the manufacture, distribution and support of ophthalmic laser systems for refractive refractive capacity to refract light. refractive error a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia. surgical applications. LaserSight Incorporated is a holding company with four operating subsidiaries engaged in the business of laser manufacturing and international sales, third-party managed vision care administration, ophthalmic practice management, and health and vision care consulting services. This press release contains forward-looking statements regarding future events and future performance of the Company that involve risks and uncertainties that could materially affect actual results. Investors should refer to documents that the Company files from time to time with the Securities and Exchange Commission for a description of certain factors that could cause actual results to vary from current expectations and the forward-looking statements contained in this press release. Such filings include, without limitation, the Company's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , Form 10-Q and Form 8-K reports and the Company's prospectus dated July 12, 1996 (File No. 333-2198). CONTACT: LaserSight Incorporated Marti Benfield, Investor Relations 314/469-3220 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion