Biolase Inc. lands 510(k) clearance for its EPIC 10 diode soft tissue laser to improve patient comfort.
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.
"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.
The FDA asks medical device manufacturers to submit documentation about controls they have in place...
Medical device and pharmaceutical companies paid out $3.5 billion to doctors and hospitals during the...
Endo International agrees to settle as many as 20,000 lawsuits filed in U.S. courts against its...
Acutus Medical secured $26.2 million in new funding for its cardiac mapping technology.