Biolase wins FDA nod for soft tissue laser

October 4, 2012 by MassDevice staff

Biolase Inc. lands 510(k) clearance for its EPIC 10 diode soft tissue laser to improve patient comfort.

Biolase logo

California-based dental laser company Biolase (NSDQ:BIOL) touted FDA clearance and CE Mark approval for its EPIC 10 diode soft tissue laser to help dentists control the laser energy level and improve patient comfort.

The next-generation diode laser technology platform includes Biolase's proprietary technology, ComfortPulse, which helps dentists precisely control the level of laser energy that penetrates the target tissue, subjecting patients to less pain.

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"This next generation diode soft tissue laser allows for cleaner cutting, superior hemostasis, improved patient comfort, and greater versatility,” said Dmitri Boutoussov, CTO of the company.  "The EPIC10 features a revolutionary and intuitive applications-based user interface with a high-resolution touch screen pre-programmed with 15 of the most commonly performed soft tissue procedures, including pain therapy, which is a highly popular treatment in the dental community for addressing pain in the oral-maxillofacial region."

The EPIC 10 is immediately for sale in the U.S. and in the countries that recognize the CE Mark, according to the press release.

CEO Federico Pignatelli said EPIC10 marked the second FDA clearance the company has received since the new management team was set up and he expected that the EPIC 10 will develop into a substantial revenue driver.