Soft tissue diode laser from Biolase receives FDA approval for several surgical uses

May 1, 2013
The EPIC 10S soft tissue diode laser from dental laser maker Biolase (NASDAQ: BIOL) has received FDA clearance for use in over 80 different indications in 19 medical markets.

The EPIC 10S soft tissue diode laser from dental laser maker Biolase (NASDAQ: BIOL; Irvine, CA) has received FDA clearance for use in over 80 different indications in 19 medical markets. Markets include ear, nose, and throat; oral surgery; arthroscopy; gastroenterology; orthopedics; general surgery; dermatology; plastic surgery; podiatry; GI/GU; gynecology; neurosurgery; ophthalmology; pulmonary surgery; cardiac surgery; thoracic surgery; urology; aesthetics; and vascular surgery.

Related: Biolase receives patent for laser technology use in eye surgery

The latest FDA approval for the EPIC 10S falls on the heels of February 2013 approval for the company's older Diolase soft tissue diode laser, explains Federico Pignatelli, Biolase chairman and CEO.

The company's diode lasers are currently used in dentistry for several surgical soft tissue procedures as an alternative to invasive and traumatic conventional devices, such as the high-speed drill, scalpel, or electrosurge. The EPIC 10 platform's 940 nm laser wavelength is well absorbed by hemoglobin (Hb) and oxyhemoglobin (HbO2), enabling efficient cutting at low power with less heat and discomfort. Disposable tips help reduce risk of infection and cross contamination, which are also FDA-cleared for tooth whitening and temporary pain relief.

Clinical studies with the EPIC 10S laser for some of its new utilities have already begun, with promising early results, says Fred Furry, Biolase COO and CFO.

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