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BIOLASE Inc Receives FDA Clearance For EPIC 10S Soft Tissue Diode Laser For Broad Spectrum Of Medical Procedures


Thursday, 11 Apr 2013 09:00am EDT 

BIOLASE Inc announced that the U.S. Food and Drug Administration (FDA) has cleared the EPIC 10S soft tissue diode laser for use as a surgical instrument for over 80 different indications in 19 medical markets including: 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, dermatology, aesthetics, and vascular surgery (see Exhibit A for a detailed listing of medical markets and indications). The EPIC 10S is the surgical model of the recently released, dental EPIC 10. BIOLASE's diode lasers are currently used in dentistry for a wide variety of surgical soft tissue procedures as an alternative to invasive and traumatic conventional devices, such as the high-speed drill, scalpel, or electrosurge. The 940nm laser wavelength of the EPIC 10 platform 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 EPIC 10 940nm wavelength diode laser uses disposable tips which help reduce the risk of infection and cross contamination and is also FDA cleared for tooth whitening and temporary pain relief. 

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26 Dec 2014