News:
Thursday May 22 10:44 AM EDT
Company Press Release
Candela announces FDA clearance of Skinscan
WAYLAND, Mass.--(BW HealthWire)--May 22, 1997--
Device improves precision of aesthetic laser surgery; To Be Marketed
With SKINLIGHT(TM) ``Kinder, Gentler'' Erbium Laser
Candela Corporation (NASDAQ:CLZR) today announced that the U.S. Food and Drug Administration (FDA) has cleared a
microprocessor- driven skin scanning device used for aesthetic laser surgery. Developed by Fotona d.d., and known as
Skinscan, it is believed to be the first scanner for an Erbium laser ever cleared by the FDA.
To be used with the SKINLIGHT Erbium: YAG laser system, Skinscan ensures consistent, precise treatment for all soft tissue
applications, such as on the face. Both Skinscan and Skinlight are manufactured for Candela by Fotona d.d., the
Slovenia-based developer of the systems. Candela holds exclusive marketing and distribution rights for these products in the
United States, Far East, South America, as well as some European and African countries.
The Skinlight Erbium laser is a versatile and advanced laser -- the ``kinder, gentler'' system -- recently cleared by the FDA for
general skin ablation. An alternative to CO2 laser treatments, Skinlight's ability to vaporize tissue layer-by-layer with surgical
precision minimizes thermal damage, which shortens the healing and recovery time. The Skinlight laser was also recently cleared
for general skin ablation through KAITECH (Korean Academy of Industrial Technology), South Korea's Ministry of Health
and Welfare.
``Skinscan represents an important step in the evolution of the Skinlight product line,'' said Gerard E. Puorro, Candela's
president and chief executive officer. ``We expect to see wide acceptance of this technology by both new and existing users of
the Skinlight system.''
Guided by a microprocessor, the Skinscan device moves the laser treatment beam over the skin for the physician, providing the
utmost precision and uniformity when treating large areas of skin during a single session. Skinscan reduces laser procedure time
and is equipped with a variety of patterned shapes and sizes.
``Skinscan provides greater control to the physician -- while increasing uniformity of treatment, especially for full-face
procedures or larger areas of skin,'' said Paul Cardarelli, Candela's product manager for dermatology.
Candela Corporation develops, manufactures, and distributes innovative clinical solutions that enable physicians, surgeons, and
personal care practitioners to treat selected cosmetic and medical problems using lasers, cryosurgery, and other proven
technologies. In addition, the company is applying its capabilities and experience with skin care and related problems to
develop a network of company-owned skin care laser centers and spas. Founded near Boston in 1970 as Candela Laser
Corporation, Candela markets and services its products in over 40 countries from offices in the United States, Europe, and the
Far East. For more information about Candela, visit the company's web site at 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.
More news for referenced ticker symbols: CLZR, and related industries: biotechnology, medical.
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