BIOLASE Announces FDA 510(K) Clearance Of ILase TM Personal Laser For Dental Market

Main Category: Dentistry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 Mar 2010 - 15:00 PDT


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.

Source
BIOLASE Technology, Inc.

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