Syneron Takes Voluntary Field Action Regarding the LiteTouch Dental Laser Product in Europe
20 Marzo 2012 - 7:00AM
Marketwired
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic
device company, announced today that its wholly owned subsidiary
Light Instruments Ltd. ("Light") has initiated a voluntary field
action regarding LiteTouch dental laser systems installed at
customers' sites in Europe. This voluntary field action is the
result of a recent test of the LiteTouch product which concluded
that some of the LiteTouch systems currently on the European market
are not fully compliant with certain Electromagnetic Compatibility
(EMC) requirements of the European Norm standard. As a result, the
CE certificate of conformity for the LiteTouch system has been
temporarily suspended. No such EMC issues exist with respect to
Light's other products.
Further to this voluntary field action, in the coming months,
Light will implement changes to the LiteTouch system hardware to
ensure that the system complies with all applicable European
standard requirements. When the CE certificate of conformity for
the LiteTouch system has been reinstated, Light will take all
necessary steps to ensure that the LiteTouch systems currently
installed in European customers' practices are fully compliant with
applicable regulations.
"The EMC compliance of our products is of fundamental importance
to Syneron and its subsidiaries," said Louis P. Scafuri, CEO of
Syneron. "We are dedicating significant resources to resolving this
issue and are confident that this process will be finalized in the
coming months."
Syneron anticipates that the costs of this field action will
have only a limited effect on its results of operations, with an
anticipated cost of $2.5-$3.5 million in one-time charges to
earnings.
About Light Instruments Light Instruments
Ltd. -- http://www.synerondental.com/ -- is a leading provider of
next generation dental laser technology for hard and soft tissue
treatments. Light, also known as Syneron Dental Lasers, is a wholly
owned subsidiary of Syneron Medical Ltd. Founded in 2005, Syneron
Dental Laser's headquarters are located in Israel.
About Syneron Medical Ltd. Syneron Medical
Ltd. (NASDAQ: ELOS) is the leading global aesthetic device company
with a comprehensive product portfolio and a global distribution
footprint. The Company's technology enables physicians to provide
advanced solutions for a broad range of medical-aesthetic
applications including body contouring, hair removal, wrinkle
reduction, rejuvenation of the skin's appearance through the
treatment of superficial benign vascular and pigmented lesions, and
the treatment of acne, leg veins and cellulite. The Company sells
its products under two distinct brands, Syneron and Candela.
Founded in 2000, the corporate, R&D, and manufacturing
headquarters for Syneron Medical Ltd. are located in Israel.
Syneron also has R&D and manufacturing operations in the US.
The Company markets, services and supports its products in 90
countries. It has offices in North America, France, Germany, Italy,
Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and
distributors worldwide.
Safe Harbor For Forward-Looking Statements
Any statements contained in this document regarding future
expectations, beliefs, goals, plans or prospects constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Further, any statements
that are not statements of historical fact (including statements
containing "believes," "anticipates," "plans," "expects," "may,"
"will," "would," "intends," "estimates" and similar expressions)
should also be considered to be forward-looking statements. There
are a number of important factors that could cause actual results
or events to differ materially from those indicated by such
forward-looking statements, including the risk that reinstatement
of the CE certification for the LiteTouch product takes longer than
expected, the risk that the cost of replacing installed LiteTouch
units with fully compliant units is more expensive than
anticipated, as well as the risks set forth in Syneron Medical
Ltd.'s most recent Annual Report on Form 20-F, and the other
factors described in the filings that Syneron Medical Ltd. makes
with the SEC from time to time. If one or more of these factors
materialize, or if any underlying assumptions prove incorrect,
Syneron Medical Ltd.'s actual results, performance or achievements
may vary materially from any future results, performance or
achievements expressed or implied by these forward-looking
statements.
In addition, the statements in this document reflect the
expectations and beliefs of Syneron Medical Ltd. as of the date of
this document. Syneron Medical Ltd. anticipates that subsequent
events and developments will cause its expectations and beliefs to
change. However, while Syneron Medical Ltd. may elect to update
these forward-looking statements publicly in the future, it
specifically disclaims any obligation to do so. The forward-looking
statements of Syneron Medical Ltd. do not reflect the potential
impact of any future dispositions or strategic transactions that
may be undertaken. These forward-looking statements should not be
relied upon as representing Syneron Medical Ltd.'s views as of any
date after the date of this document.
Investor Contacts: Asaf Alperovitz Chief Financial
Officer + 972 73 244 2283 Email: Email Contact Zack Kubow The Ruth
Group 646-536-7020 Email: Email Contact
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