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BIOLASE Receives FDA Clearance for New Diode Soft Tissue Laser

Posted on Wednesday, October 9, 2013


IRVINE, CA -- (Marketwire) -- The US Food and Drug Administration (FDA) has cleared BIOLASE Inc.’s 940nm Diolase 10 diode soft tissue laser for use in 19 additional medical markets, according to the company. These markets include: ear, nose and throat, oral surgery, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, GI/GU, gynecology, neurosurgery, ophthalmology, pulmonary surgery, cardiac surgery, thoracic surgery, urology, dermatology, aesthetics, and vascular surgery.

This FDA clearance includes over 80 different procedures. "We are very pleased to receive clearance for such a broad number of indications and procedures for the Diolase 10 diode soft tissue laser. Obtaining clearance for so many procedures across such a wide range of medical markets clearly demonstrates that our diode laser products are well suited for a vast array of surgical procedures," said Federico Pignatelli, Chairman and Chief Executive Officer.

"Clearance for our Diolase 10 is the first step in enabling us to leverage our recently released, next-generation 940nm EPIC 10™ modular diode soft tissue dental laser platform and consumable business across a wide range of multi-billion dollar medical markets with appropriate strategic partners," continued Pignatelli.

BIOLASE's diode lasers are used in dentistry for surgical soft tissue procedures as an alternative to invasive and traumatic conventional devices, such as the high-speed drill, scalpel or electrosurge. BIOLASE's 940nm wavelength is also FDA cleared for tooth whitening and temporary pain relief in a number of BIOLASE products.

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