BIOLASE, Inc. (BIOL) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and Conformité Européene (CE) Mark approval for its EPIC 10™ diode soft tissue laser.
EPIC™ offers the most precise control of tissue cutting for different procedures and tissue biotypes. With our exclusive diode laser wavelength, EPIC™ cuts soft tissue cleaner, with more hemostasis and supreme patient comfort. Take advantage of other EPIC capabilities including relief of lesions (aphthous ulcers, herpetic lesions) as well as performing “pocket therapy” using single-use disposable Perio tips.
EPIC™ is an ideal teeth-whitening solution for progressive offices wanting to expand their cosmetic treatment menu. Studies have shown that EPIC™ can perform a full-mouth, in-office whitening procedure with an average of 4-6 shades in only 20 minutes of treatment time (not including set-up or take-down), faster than any other in-office whitening system.* And with LaserGel20 whitening gel kits available in five-packs, it’s a reliable, affordable treatment that can generate EPIC return on your investment.
EPIC™ is cleared by the U.S. FDA for Pain Therapy, a North America exclusive for dental diode lasers. Using a deluxe, fully engineered Deep Tissue Handpiece (DTHP) to control important parameters such as spot size, you have EPIC capabilities for temporary relief of minor pain in the oral maxillofacial region.
Federico Pignatelli, Chairman and Chief Executive Officer, commented:
We are extremely pleased to have received FDA clearance and the CE Mark for the EPIC 10, the next generation of our diode laser technology platform. These are very significant milestones for BIOLASE. It also marks the second FDA clearance received since the new management team was put in place under my leadership. With its superior technology and design features, and total suite of treatment offerings, we expect that the EPIC 10 will develop into a substantial revenue driver.
Offering of EPIC 10 for sale in the U.S. has been initiated on October 1st; Commercial sales throughout the European Union and in those Asian and Latin American countries that recognize the CE Mark have been started at third quarter of 2012.
Irvine, CA 92618
BIOLASE is revolutionizing surgery in dentistry and medicine with WaterLase technology. BIOL specializes in the development, manufacturing and marketing of lasers and related products to provide biological treatments that eliminate pain and are safer for patients.