A Medical Device Daily Staff Report

Biolase Technology (Irvine, California) reported that Discus Dental (Culver City, California) and Zap Lasers (Pleasant Hill, California) have filed a lawsuit against Biolase in the U.S. District Court for the Central District of California, alleging patent and trademark infringement, unfair trade practices, and unfair competition involving Biolase's iLase diode laser.

According to Biolase, the allegations are merely based on the shape of the iLase, and are not based at all on the ground breaking functions of the laser unit itself. The lawsuit was filed by the plaintiffs without first contacting Biolase, the company noted.

"We are very confident in the breadth of our intellectual property portfolio, and in the strength of our laser technology, and we intend to vigorously defend the company against these allegations levied by Discus and Zap," said Biolase CEO David Mulder.

In March, Biolase received FDA 510(k) clearance to market its iLase diode laser, the world's first personal laser for dentists and hygienists, 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, according to Biolase.

"The plaintiffs contend that the design of the iLase is likely to cause confusion among purchasers and potential purchasers of laser devices," Mulder said. "But the plaintiffs' product is a diode laser with less than half the power, fewer features, of different physical design and size with a fixed angle tip versus our nine adjustable tips, and about double the price of the iLase — so we dispute their allegations, and believe the plaintiffs may be having difficulty competing with the iLase. We do know that in January 2010, the FDA forced Zap to recall more than 1,000 of their other dental lasers. In addition, while their product requires a cumbersome foot pedal to be used, the iLase is the only truly self-contained laser unit with no foot pedal."

"We look forward to our day in court," Mulder added, "and we are carefully exploring all options available to us, as the iLase has been in development since 2006. Our first iLase units are coming off the production line now, and we have been taking orders in the United States and around the world. As our European CE mark was received prior to our FDA 510(k) clearance, most of the orders received to date are for international markets."

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