BIOLASE, Inc. Announces FDA Clearance and Worldwide Launch of New Epic Pro Diode Laser System
January 23, 2017 at 06:00 am EST
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BIOLASE, Inc. announced its Epic Pro laser system, a new, innovative dental diode laser system that offers higher laser power, has received 510(k) clearance for commercial distribution from the U.S. Food and Drug Administration (FDA). The Epic Pro laser system, which received marketing authorization in select international markets late last year, can now be sold in the U.S. The new addition to the company’s Epic portfolio of soft-tissue diode lasers, Epic Pro offers important advancements in cutting speed, control, precision and improvements in consistency and predictability.
BIOLASE, Inc. is a medical device company that develops, manufactures, markets and sells laser systems in dentistry and medicine. The Company's systems allow dentists, periodontists, endodontists, pediatric dentists, oral surgeons, and other dental specialists to perform a broad range of minimally invasive dental procedures, including cosmetic, restorative, and complex surgical applications. It offers two categories of laser system products: Waterlase (all-tissue) systems and diode (soft-tissue) systems. The Company's all-tissue Waterlase dental laser systems consist of its flagship Waterlase iPlus, Waterlase Express, and Waterlase MDX. Its soft tissue diode laser systems consist of the Epic X, Epic Hygiene, Epic Q, and Epic 10 diode lasers that perform soft tissue, hygiene, cosmetic procedures, teeth whitening, and provide temporary pain relief. Epic X, and Epic 10 systems feature its 940 nanometer wavelength with patented pulse technology called ComfortPulse.