Syneron Medical Ltd. Takes Voluntary Field Action Regarding the LiteTouch Dental Laser Product in Europe
Published: Mar 20, 2012
YOKNEAM, ISRAEL--(Marketwire - March 20, 2012) - 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.
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