LaserSight LaserScan LSX Excimer Laser Approved for Sale in Europe.

ORLANDO, Fla.--(BW HealthWire)--Oct. 9, 1998--LaserSight Incorporated (Nasdaq:LASE) announced today that its wholly owned subsidiary, LaserSight Technologies, Inc., has received European approval for its state-of-the-art model LaserScan LSX(tm) excimer laser through certification to apply the CE Mark. The CE Mark approval indicates that the LaserScan LSX has demonstrated safety and effectiveness and compliance to the European Community's Medical Device Directives, a requirement for sales into its 15 member countries since June 1998.

"Receiving certification for the CE Mark allows us to deliver the LaserScan LSX, our state-of-the-art scanning technology platform and software to ophthalmologists within the European Community," said Michael R. Farris, chief executive officer of LaserSight. Inc. "With its capability to correct refractive errors including myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (irregular shape), we believe the LaserScan LSX will occupy a strong position in the European market for refractive surgery. The European market is experiencing an increase in the number of laser refractive surgeries due to the emergence of the LASIK procedure. CE mark certification is therefore timely, as the LSX has been utilized almost exclusively for LASIK.

The CE Mark applied to a product indicates its conformance to international standards of quality and demonstration of safety and efficacy. The LaserScan LSX system is considered a Class II(b) device under the European Medical Devices Directive. Compliance with requirements of the Directives was determined by Type Testing at SEMKO.

CE marking was made possible by receipt of the Certificate of Conformity to the European Medical Devices Directive, 93/42/EEC. LaserSight previously announced during October 1996 that it received certification to the EN ISO 9002 and EN 46002 Quality Management Systems and Annex V of the European Medical Devices Directive (93/42/EEC) by SEMKO, which is a requirement for CE Mark. SEMKO is accredited by SWEDAC and is recognized as the foremost Notified Body in Europe. Certification to ISO 9002 was also 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 surgical applications.

The completion of ISO 9002 and other CE Mark requirements is further demonstration of LaserSight's commitment to manufacturing and quality assurance standards and evidence of progress towards compliance to the United States Food and Drug Administration's Good Manufacturing Procedures.

LaserSight Incorporated provides quality technology solutions for laser refractive surgery and other innovative applications, especially in the vision correction industry. The company sells its products in more than 30 countries. In the United States, LaserSight's refractive scanning laser system has had a pending pre-market approval application with the U.S. Food and Drug Administration since May of this year, and is not yet commercially available in that market.

This press release contains forward-looking statements regarding future events and future performance of the Company. These statements are subject to 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 the 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-Q and Form 8-K reports.