Dental News - First hand-held dental laser approved by US regulators

Daniel Zimmermann, DTI

Thu. 18 March 2010

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NEW YORK, USA/LEIPZIG, Germany: The US Food & Drug Administration (FDA) has given 510(k) clearance to iLase, the world's first hand-held dental laser from Biolase. The decision will give the California-based manufacturer the right to market their new product in the USA and other countries worldwide. Shares of the company went up over 20 per cent yesterday morning after the clearance was announced by the regulators.

FDA 510(k) clearance or Premarket Notification must be submitted by all manufacturers that wish to introduce Class 2 medical devices to the US. Biolase received the FDA's approval just after they introduced the iLase at the CDS Midwinter Meeting in Chicago in February. The company announced that they will start shipping the device in April.

As first self-contained dental laser on the market, iLase integrates the battery power, user interface and controls in one single pen-like handpiece with no foot pedals or cords attached. It comes equipped with Biolase's proprietary ComfortPulse control that allows tissue to cool between pulses for improved patient comfort, company officials said.

They added that the laser will be able to perform 25 FDA-cleared soft tissue and hygiene procedures including gingivectomies, sulcular debridement or the treatment of periodontal disease.

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