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BIOLASE Inc Receives FDA Clearance And CE Mark For EPIC 10 Diode Soft Tissue Laser

Wednesday, 3 Oct 2012 09:00am EDT 

BIOLASE Inc announced that it has received 510 clearance from the U.S. Food and Drug Administration (FDA) and Conformite Europeene (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. 

Company Quote

-0.03 -1.27%
11:05am EDT