High-Power Diode Laser Gets FDA Approval

BIOLASE has received 510(k) clearance from the US Food and Drug Administration for its Epic Pro laser system, which means it now can be sold in the United States. According to the company, the Epic Pro offers advances in cutting speed, control, precision, consistency, and predictability. It also is the first commercially available laser system resulting from BIOLASE’s strategic development agreement with IPG Medical.

“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,” said IPG Medical president Gregory Altshuler, PhD. “This new feature is a very significant innovation that we believe will provide the technological basis for other clinical modalities.”

BIOLASE reports that the Epic Pro can achieve 10 times the peak power of a standard diode laser and up to 3 times the peak power of its closest competitor in short micropulses for top soft-tissue cutting efficiency and safety. The company also states that it cuts 4 times faster than a classic diode laser with minimal collateral damage. Powered on only about 3% to 5% of the time, the laser gives the tissue ample time to relax between pulses for a safer and gentler patient experience as well.

Plus, BIOLASE says, the Epic Pro’s 7-inch display is larger than any other diode laser’s display, with a graphical user interface that employs intuitive procedural categories, more than 20 factory presets, and access to favorite settings. Its quick start mode enables fast initiation of treatment, with standard and advanced modes for control and flexibility designed to match the user’s skill level. Applications include laser pocket therapy, gingival troughing, aphthous ulcers, implant uncovery, frenectomies, soft-tissue crown lengthening, and excisions for biopsy.

“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,” said BIOLASE president and CEO Harold C. Flynn Jr. “This advanced new laser system also provides us a platform for the future expansion of our capabilities and indications.”