Biolase Gets FDA Clearance And CE Mark For EPIC 10 Diode Soft Tissue Laser
Posted on October 4, 2012
(RTTNews) - Biolase Inc. (BIOL:Quote) announced Wednesday that it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA and Conformité Européene or CE Mark approval for its EPIC 10 diode soft tissue laser. BIOLASE initiated commercial sales in the final days of the third quarter of 2012 throughout the European Union and in those Asian and Latin American countries that recognize the CE Mark.
The company received notification of clearance from the FDA on October 1, 2012, and immediately began offering the EPIC 10 for sale in the U.S.