Business Services Industry
Candela Earns "CE" Mark For GentleLASE; Certification Opens Up European Market for Sales of Company's New Hair Removal Laser
Business Wire, August 6, 1998
WAYLAND, Mass.--(BUSINESS WIRE)--Aug. 6, 1998--Candela Corporation (NASDAQ:CLZR), a leading developer of aesthetic laser systems, today announced that it has been issued CE certification for compliance with the Medical Device Directive (MDD) for its new low-cost laser system for hair removal, the GentleLASE(tm). This enables the company to market and sell the system in the 15 EU countries.
The Conformite Europeenne, or CE, is the official mark required by the EU for all electric and electronic equipment sold in the European Community. It indicates that a product complies with specific standards in the areas of health, safety, the environment, and consumer protection.
Gerard E. Puorro, Candela's president and chief executive officer, stated: "Since receiving clearance from the FDA for use of the GentleLASE as a hair removal device, we have seen an unprecedented demand for the system and made significant inroads in building market share. CE certification opens up a whole new market for us -- one with great potential. We are looking forward to a fast start in Europe and to establishing the same kind of market presence that we have been able to quickly develop with the GentleLASE in the U.S."
Candela's GentleLASE is the premier hair removal laser system available today, offering the fastest treatment and unsurpassed clinical effectiveness at the industry's most affordable price.
Candela's GentleLASE is the premier hair removal laser system available today, offering the fastest treatment and unsurpassed clinical effectiveness at the industry's most affordable price.
In addition, GentleLASE is the first and only hair removal laser available with dynamic cooling. Candela's proprietary Dynamic Cooling Device(tm) (DCD) selectively cools the upper layers of skin prior to the laser pulse, minimizing pain and reducing thermal exposure to the epidermis and upper layers of the skin.
William D. Spies, Candela's senior vice president of marketing, sales, and service, said: "The GentleLASE represents a great breakthrough in technology and efficacy, as well as cost. With a selling price that's 40 to 50% less than competitive systems, we anticipate continued strong sales of the GentleLASE here in the U.S. and internationally." According to Spies, hair removal in the U.S. alone is estimated to be a billion dollar a year market.
About Candela
Candela Corporation develops, manufactures, and distributes innovative clinical solutions that enable physicians, surgeons and personal care practitioners to treat selected cosmetic and medical conditions using lasers, cryosurgery and other proven technologies. Founded near Boston in 1970, Candela markets and services its products in over 40 countries from offices in the United States, Europe and Asia. Candela established the aesthetic laser market 11 years ago. With an installed base of over 2,000 lasers worldwide, more than 500,000 aesthetic laser procedures are performed annually with Candela laser systems. For more information about Candela, visit the company's web site at http://www.clzr.com.
This press release includes certain forward-looking statements. Any such statements are subject to risks that could cause the actual results to vary materially, including negative developments relating to unforeseen order cancellations or push-outs, Candela's strategic relationships, the impact of intense competition and changes in the laser industry.
CONTACT: Candela Corporation
Jane Smith: 508-358-7400 (Ext. 247)
or
Phase Two Strategies
Stuart Pearlman: 212-716-3400
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