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Premier Laser Systems Receives FDA 510(k) Clearance to Market Its New Proprietary Solid State Technology for Composite Curing, Teeth Whitening IRVINE, Calif., Sep 1, 1999 (BUSINESS WIRE) -- Premier Laser Systems Inc (Nasdaq/NM:PLSIA) today announced that the Company has received 510(k) clearance from the FDA to market the Company's new proprietary solid-state light delivery system, BluLaze(TM), for both composite curing and teeth whitening. The semiconductor technology of BluLaze is an industry first for composite curing, offering the dental market a curing system that can also be used for teeth whitening procedures with no gases to refill and no lamps or light filters to replace. The portable, five-lb. unit, which is approximately the size of a telephone, will have a list price of just under $5,000. It will debut at the California Dental Association meeting September 16-18 at Moscone Center in San Francisco. "BluLaze offers the dental market an entirely new high technology solution for composite curing and teeth whitening," said Premier President and CEO Colette Cozean, Pd.D., "and for the dentist, BluLaze is a highly-affordable stepping stone for building a high tech dental practice." American Dental Association statistics have previously shown that resin-based composites were estimated to be used in nearly 50 million private practice dental procedures yearly, with that number growing as composites continue to replace metal-based amalgams. Additionally, other industry sources estimate that about 70 percent of U.S. dental practitioners perform teeth whitening procedures using take-home bleaching kits, lasers or other means. Company-sponsored laboratory studies indicate that BluLaze offers more efficiency in its pure curing energy delivery than standard halogen or arc plasma curing lamps. BluLaze takes only three seconds to cure a standard two- to three-mm layer of dental composite material, compared with five to 10 seconds for the average plasma arc source and 40 seconds for the conventional halogen bulb. In addition, BluLaze cured composites at a depth of 5.6 mm to 8 mm, compared to 4.5 mm to 5.9 mm maximum for plasma arc and other lamp technologies. Premier Laser Systems develops, manufactures and markets diagnostic and therapeutic products for the eyecare, dentistry and surgical markets including lasers, fiber optic delivery systems and associated products for a variety of applications. The statements in this release that relate to future events or performance, statements about growth, future availability of components, levels of sales and market size, future manufacturing capacity and efficiencies, future product shipment rates, future FDA submittals and future product introductions are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to the development of markets for and commercial acceptance of the company's products and services, the availability of components, competitors product introductions and other risks identified in the Company's SEC filings. Actual results may differ from those described in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Copyright (C) 1999 Business Wire. All rights reserved. CONTACT: Allen & Caron Inc Owen Daley (media), 714/957-8440 owen@allencaron.com or Matt Clawson (investors), 714/957-8440 matt@allencaron.com or www.premierlaser.com WEB PAGE: businesswire.com GEOGRAPHY: CALIFORNIA INDUSTRY CODE: COMPUTERS/ELECTRONICS COMED MEDICINE PRODUCT BIOTECHNOLOGY | ||||||||||||
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