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FDA Clears BIOLASE’s Diolase 10 Diode Soft Tissue Laser for Broader Medical Procedures

BIOLASE, Inc., the world's leading manufacturer and distributor of dental lasers, announced today that the U.S. Food and Drug Administration (FDA) has cleared the 940nm Diolase 10 diode soft tissue laser for use in 19 additional medical markets including: 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. The 940nm wavelength is better absorbed by hemoglobin (Hb) and oxyhemoglobin (HbO2) than other diode laser wavelengths, so it cuts efficiently at low power and with considerably less heat and discomfort, making it an excellent alternative to conventional surgical devices. BIOLASE's 940nm wavelength is also FDA cleared for tooth whitening and temporary pain relief in a number of BIOLASE products.

"This is an exciting time at BIOLASE as we continue to expand the capabilities, applications, and indications for our core technologies so that they can be leveraged within our core dental market as well as into a number of other promising medical and veterinary markets," said Fred Furry, Chief Operating Officer and Chief Financial Officer. "We will use the clearances received for the Diolase 10, now established as a 940nm diode laser predicate device, to obtain the same clearances for our EPIC 10 platform, which uses the same wavelength."

"In conjunction with the Oculase MD, the 940nm diode laser is a surgical tool that every ophthalmology and oculoplastic practice should consider adding. It will allow the practitioner to offer more in-office surgery procedures to patients, rather than taking the time and expense incurred with the use of a surgery center," said Daniel Durrie, M.D., internationally-recognized refractive surgeon and founder of Durrie Vision, a world-class refractive surgery center and research department located in the Kansas City area.


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