Light Instruments, also known as Syneron Dental, has initiated a voluntary field action regarding LiteTouch dental laser systems installed at customer 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, according to the company.
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.
Light Instruments plans to 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.
