Candela Announces Expanded FDA Clearances for New GentleYAG Laser.Business Editors/Health/Medical Writers WAYLAND, Mass.--(BUSINESS WIRE)--Nov. 10, 2003 Candela candela (kăndĕ`lə), in weights and measures: see candle. A unit of measurement of the intensity of light. Part of the SI system of measurement, one candela (cd) is the monochromatic radiation of 540THz with a radiant intensity Corporation (NASDQ: CLZR) announced today that it has received U.S. Food and Drug Administration (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. ) clearance for its new GentleYAG(TM) 1064nm Nd:YAG laser opening access to new markets and a multitude of new clinical applications. In addition to hair removal, the new GentleYAG is now cleared for the following indications: permanent hair reduction on all skin types including tanned skin, pseudofolliculitis barbae Pseudofolliculitis barbae (pronounced /'suː.dɒ.fɒ.lɪk.kjuːˌliː.tɪs 'bɑː.beɪ/) is a medical term for persistent inflammation caused by shaving. (beard bumps), pigmented and vascular lesions including leg veins, spider veins, warts, age and sun spots (Astron.) dark spots that appear on the sun's disk, consisting commonly of a black central portion with a surrounding border of lighter shade, and usually seen only by the telescope, but sometimes by the naked eye. , and wrinkles. Gerard E. Puorro, Candela's President and Chief Executive Officer, commented: "The new GentleYAG is representative of our continued efforts to put the most flexible lasers into the hands of our customers. We are very pleased to gain these additional clearances from the FDA as it enables us to offer the most comprehensive product portfolio in the industry." The new GentleYAG offers several new features including variable pulse durations, multiple spot sizes, as well as an increased repetition rate for even faster treatments all packaged in a smaller, more transportable laser system. Puorro continued, "We listened to our customers and went back to the drawing board to modify our Nd:YAG to meet their needs. We feel our new GentleYAG is now the premier Nd:YAG laser on the market today." The GentleLASE(R) portfolio of lasers also includes Candela's best selling laser of all time, the GentleLASE 755 nm alexandrite alexandrite type of chrysoberyl typifying undying devotion. [Gem Symbolism: Jobes, 67] See : Loyalty laser, as well as the GentleLASE Limited Edition(TM) and the GentleYAG Limited Edition lasers. 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 See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. using lasers, aesthetic laser systems, and other advanced technologies. Founded near Boston in 1970, the company markets and services its products in over 60 countries from offices in the United States, Europe, Japan and other Asian locations. Candela established the aesthetic laser market 15 years ago, and currently has an installed base of over 6,500 lasers worldwide. Candela is an Equal Opportunity and Affirmative Action affirmative action, in the United States, programs to overcome the effects of past societal discrimination by allocating jobs and resources to members of specific groups, such as minorities and women. Employer, M/F/H/V M/F/H/V Male/Female/Handicapped/Veteran (employment) . Visit Candela on the Web at http://www.candelalaser.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement: Except for the historical information contained herein, this news release contains forward-looking statements that constitute Candela's current intentions, hopes, beliefs, expectations or predictions of the future, which are therefore inherently subject to risks and uncertainties. Candela's actual results could differ materially from those anticipated in Candela's forward-looking statements based on various factors, including without limitation: the cancellation or deferral of customer orders, dependence on a small number of strategic distribution relationships, difficulties in the timely development and market acceptance of new products, market developments that vary from the current public expectations concerning the growth of the laser industry, increased competitive pressures, or changes in economic conditions. Further information on factors that could affect Candela's performance is included in Candela's periodic reports filed with the SEC, including but not limited to, Candela's Annual Report on 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. for the year ended June 28, 2003. Candela cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Candela expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Candela's expectations or any change in events, conditions or circumstances on which any such statement is based. |
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