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Biolase Gets FDA Clearance For Dental Device iLase

Biolase Technology, a developer of dental laser medical devices, has received 510(k) clearance to market its iLase diode laser, a new personal laser for dentists and hygienists for performing a full-range of minimally invasive soft-tissue and hygiene procedures.

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

The iLase, which is about the size of a large pen and has five watts of power, is the dental laser controlled by a patent-pending finger switch on the laser handpiece, which eliminates the need for a foot control pedal. It also uses Biolase’ 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.

Biolase said that the iLase can perform a comprehensive set of 25 FDA-cleared soft tissue and hygiene procedures like the ezlase. 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 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.

David Mulder, chief executive officer of Biolase, 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 US and around the world and are on schedule to begin shipping in April.”