Some of the LiteTouch dental laser systems sold through Syneron subsidiary Light Instruments were deemed "not fully compliant" with electromagnetic compatibility requirements, standards designed to keep machines from unintentionally interfering with each other.
Syneron launched a field action regarding LiteTouch devices installed at customer sites in Europe, a measure that may take $2.5-$3.5 million off of the Israel-based aesthetics devices maker’s bottom line.
"The EMC compliance of our products is of fundamental importance to Syneron and its subsidiaries," CEO Louis Scafuri said in prepared remarks. "We are dedicating significant resources to resolving this issue and are confident that this process will be finalized in the coming months."
Syneron plans to alter the LiteTouch system’s hardware to ensure that the device meets EU EMC standards. Once the device has regained its CE Mark status, the device maker will "take all necessary steps to ensure that the LiteTouch systems currently installed in European customers’ practices are fully compliant with applicable regulations," according to a press release.
The aesthetics company has had a slew of recent news, including an announcement earlier this month that it signed a definitive agreement to acquire transdermal drug delivery firm TransPharma Medical for $3.6 million in cash, a deal which had earlier been rumored at $15 million. Syneron also closed a $12 million buyout of Ultrashape Ltd. this month.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.