BIOLASE Receives FDA Clearance for Its 940nm Diolase 10(TM) Diode Soft Tissue Laser for a Broad Spectrum of Medical Procedures

BIOLASE Receives FDA Clearance for Its 940nm Diolase 10(TM) Diode Soft Tissue 
Laser for a Broad Spectrum of Medical Procedures 
Clearance for Over 80 Procedures in 19 Additional Medical Markets 
IRVINE, CA -- (Marketwire) -- 02/06/13 --  BIOLASE, Inc. (NASDAQ:
BIOL), 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(TM)
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(1), 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
"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
"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. 
BIOLASE will be exhibiting its 940nm EPIC 10 diode soft-tissue laser
for dental procedures, tooth whitening, and pain therapy, as well as
its many other dental products, at several upcoming conferences
including: the Western Veterinary Medical Conference from February
17-21 in Las Vegas, NV; the 148th Mid-Winter Meeting from February
21-23 in Chicago, Illinois; and the International Dental Show from
March 12-16 in Cologne, Germany.  
About BIOLASE, Inc.
 BIOLASE, Inc. is a biomedical company that
develops, manufactures and markets dental lasers and also distributes
and markets dental imaging equipment; products that are focused on
technologies that advance the practice of dentistry and medicine. The
Company's laser products incorporate approximately 290 patented and
patent-pending technologies designed to provide biological treatment
and clinically superior performance with less pain and faster
recovery times. Its imaging products provide cutting-edge technology
at competitive prices to deliver the best results for dentists and
patients. BIOLASE's principal products are dental laser systems that
perform a broad range of dental procedures, including cosmetic and
complex surgical applications, and a full line of dental imaging
equipment and CAD/CAM systems. BIOLASE has sold more than 21,000
Other products under development address ophthalmology and other
medical and consumer markets.  
For updates and information on WaterLase and laser dentistry, find
BIOLASE online at, Facebook at, Twitter at, and
YouTube at  
(1) Tuner, Jan & Hode, Lars. The New Laser Therapy Handbook. Fig
1.14, 41-42. Graengesberg, Sweden: Prima-Books, 2010. See graphical
illustration in Attachment A. 
For further information, please contact: 
Lisa Wilson 
In-Site Communications, Inc. 
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