Biolase Soft Tissue Diode Laser Cleared by FDA
IRVINE, Calif., April 12, 2013 — Biolase Inc.’s EPIC 10S soft tissue diode laser has received FDA clearance for use as a surgical instrument in more than 80 applications in 19 medical markets.
“This clearance gives us the ability to leverage our EPIC 10 modular soft tissue diode laser platform and consumable business across a wide range of multibillion-dollar medical markets with appropriate strategic partners or in a direct mode,” said Federico Pignatelli, chairman and CEO. The clearance is based on one the company received in February 2013 for its older Diolase soft tissue diode laser.
Biolase’s dental lasers are used in a variety of surgical soft tissue procedures as an alternative to invasive, traumatic conventional devices, such as the high-speed drill, scalpel or electrosurge. The EPIC 10 platform’s 940-nm wavelength is better absorbed by hemoglobin and oxyhemoglobin than other wavelengths, making cutting procedures more efficient at low power and with considerably less heat and discomfort. The device uses disposable tips to reduce the risk of infection and cross contamination and is also FDA-cleared for tooth whitening and temporary pain relief.
It has been cleared for markets including: ear, nose and throat; oral, general, plastic, pulmonary, cardiac, thoracic and vascular surgery; arthroscopy, gastroenterology, orthopedics, dermatology, podiatry, GI/GU, gynecology, neurosurgery, ophthalmology and aesthetics.
“We have already begun performing clinical studies for a variety of these new applications, and some of our early results have been extraordinary,” said Fred Furry, chief operating and financial officer. “Our plan remains to focus on growing our core laser business in the dental market, but we will also continue to expand the capabilities, applications and indications for these core technologies in other medical markets as well.”
For more information, visit: www.biolase.com
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