Healthcare Industry News:  BIOLASE  

Devices Dental FDA

 News Release - March 16, 2010

BIOLASE Announces FDA 510(K) Clearance of iLase (TM) Personal Laser for Dental Market

Completely Self-Contained Laser for Full Range of Minimally Invasive Soft-Tissue, Hygiene Procedures

IRVINE, CA - (HSMN NewsFeed) - BIOLASE Technology, Inc. (NASDAQ:BLTI ), the world's leading dental laser company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its iLase™ diode laser, the world's first personal laser for dentists and hygienists for performing a full-range of minimally invasive soft-tissue and hygiene procedures.

The iLase is the first completely self-contained, hand-held dental laser that includes the laser, user interface, battery power, and controls in a single, integrated handpiece with no foot pedals or cords attached.

BIOLASE Chief Executive Officer David M. Mulder said, "The iLase represents another milestone for BIOLASE and another example of our leadership in the global dental laser market. We call the iLase a revolutionary breakthrough because there is nothing else like it on the market. The iLase was created to be simple and intuitive and, after introducing it at the Chicago dental show last month, it has already generated global interest and demand, along with prepaid orders. We look forward to offering this to our customers in the U.S. and around the world and are on schedule to begin shipping in April."

The iLase, which is about the size of a large pen and has five watts of power, is the only dental laser controlled by a patent-pending finger switch on the laser handpiece, which uniquely eliminates the need for a foot control pedal. It also uses BIOLASE's proprietary ComfortPulse™ control that lets clinicians adjust the laser for maximum patient comfort and cutting speed.

The iLase has 10 completely pre-set soft tissue and hygiene procedures at the push of a button, including gingivectomy, troughing for crown procedures and sulcular debridement, and a procedure for cleaning between gums and teeth for the treatment of periodontal disease. Like the ezlase™, the iLase can perform a comprehensive set of 25 FDA-cleared soft tissue and hygiene procedures. For a full diode solution, the ezlase goes beyond the basic iLase with 20-minute teeth whitening and FDA-cleared pain relief functions. Beyond all diode lasers, the Waterlase® MD Turbo™ is the very best soft-tissue laser with a virtually painless "cold cut" water-based wavelength, and the Waterlase provides the substantial added benefits of virtually painless procedures on teeth and bone, periodontal procedures and much more.

For more information on the iLase, contact BIOLASE at 1-877-670-4767.

About BIOLASE Technology, Inc.

BIOLASE Technology, Inc. (, the world's leading dental laser company, develops, manufactures and markets Waterlase technology and lasers and related products that advance the practice of dentistry and medicine. The Company's products incorporate patented and patent pending technologies designed to provide clinically superior performance with reduced pain and faster recovery times. BIOLASE's principal products are dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. Other products under development address ophthalmology, pain management and other medical and consumer markets.

This press release may contain forward-looking statements within the meaning of safe harbor provided by the Securities Reform Act of 1995 that are based on the current expectations and estimates by our management. These forward-looking statements can be identified through the use of words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," "may," "will," and variations of these words or similar expressions. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks, uncertainties and other factors which may cause the Company's actual results to differ materially from the statements contained herein, and are described in the Company's reports it files with the Securities and Exchange Commission, including its annual and quarterly reports. No undue reliance should be placed on forward-looking statements. Such information is subject to change, and we undertake no obligation to update such statements.

Source: BIOLASE Technology

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