FDA Clears BIOLASE Diode Laser Dentistry System

BIOLASE Inc., announced today its Epic Pro laser system, a new dental diode laser system that offers higher laser power than most diode lasers in dentistry, has received 510(k) clearance for commercial distribution from the U.S. Food and Drug Administration (FDA). The Epic Pro laser system, which received marketing authorization in select international markets late last year, can now be sold in the U.S.
 
The newest addition to the Company’s Epic portfolio of soft-tissue diode lasers, Epic Pro offers important advancements in cutting speed, control, precision and improvements in consistency and predictability.
 
The Epic Pro is the first commercially available laser system resulting from BIOLASE’s strategic development agreement with IPG Medical Corporation, a subsidiary of IPG Photonics Corporation, reached in 2015.
 
“The collaboration between IPG Medical and BIOLASE has been exciting,” said IPG Medical president Gregory Altshuler, Ph.D. “The Epic Pro with IPG Medical’s super pulse diode laser offers all new computer-controlled thermal super pulsing capability with real-time tip temperature monitoring and automatic power control designed to assist dentists in performing procedures quickly and with great precision. This new feature is a very significant innovation that we believe will provide the technological basis for other clinical modalities.”
 
BIOLASE President and CEO Harold C. Flynn, Jr. noted that the Company’s worldwide launch is now underway with systems available for delivery in the U.S. and select international markets.
 
“We are proud to expand the BIOLASE product portfolio by introducing the Epic Pro as our premium diode laser solution. There is nothing else like it on the market,” Flynn said. “The high end capabilities of this new laser, such as its cutting speed, power and control, allow us to access market segments we have not been able to before, such as the oral and maxillofacial surgeon markets, which previously had not been interested in diode lasers. This advanced new laser system also provides us a platform for the future expansion of our capabilities and indications. Epic Pro represents our ongoing commitment to elevating the standard of care in dentistry, and achieving better patient reported outcomes while enabling clinicians to realize better business returns.”