FDA grants 510(k) clearance for Biolase’s Waterlase Express dental laser

12 February 2017 (Last Updated November 22nd, 2018 11:23)

The US Food and Drug Administration has granted 510(k) clearance for the commercial distribution of the medical device firm Biolase's new fifth-generation all-tissue laser system Waterlase Express.

FDA grants 510(k) clearance for Biolase’s Waterlase Express dental laser

The US Food and Drug Administration has granted 510(k) clearance for the commercial distribution of the medical device firm Biolase's new fifth-generation all-tissue laser system Waterlase Express.

The device is equipped with compact, miniaturised version of patented Waterlase Er,Cr:YSGG laser engine and contra-angle handpiece to allow better clinical intraoral access.

Waterlase Express features cloud-based software, support content delivery and remote diagnostics along with side-firing tips for easy removal of implant thread.

The laser is claimed to be helpful to perform various dental procedures such as sub-gingival decay removal, frenectomy techniques, flap surgery, closed crown lengthening and implant debridement.

Biolase president and chief executive officer Harold Flynn said: "With all the value of Waterlase technology at nearly one-quarter the size, one-third the weight, and nearly half the US retail price of our market-leading Waterlase iPlus system, we believe Express is the dental laser that is finally ready for the vast majority of dentists around the world, many of whom have waited to integrate our all-tissue laser solutions into their practices."

"We believe Express is the dental laser that is finally ready for the vast majority of dentists around the world, many of whom have waited to integrate our all-tissue laser solutions into their practices."

The device includes one-touch access to Biolase customer care from the laser control screen, a Connect system to a network of resources and video tutorials, which enable easy maintenance and care of the laser.

The simple, one-slider cutting adjustment control of Waterlase Express is claimed to enable procedure presets, while its tablet-based interface allows easy usage.

The new dental laser is currently available for dentists in the US and select markets in Europe, the Middle East and Asia.


Image: Biolase Waterlase Express all-tissue laser system. Photo: courtesy of Biolase.