Soft tissue diode laser given FDA clearance

Feb. 9, 2007
BIOLASE's ezlase system granted approval.

IRVINE, California--BIOLASE Technology, Inc. has announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market ezlase, a new soft tissue diode laser system (patents pending).

"The new ezlase laser system is an important component of our overall dental laser market strategy and the perfect complement to our flagship product, the Waterlase MD," commented Jeffrey W. Jones, President and CEO.

"We have devoted significant resources to make BIOLASE the leader in dental lasers and in dental laser brand name recognition. Now that we have a strategic alliance with dental powerhouse Henry Schein, the timing couldn't be better to launch this hand-sized, state-of-the-art, feature-rich soft-tissue dental laser system. Once again, BIOLASE is setting the standard."

The new ezlase diode laser includes numerous benefits aimed at providing cleaner cutting and faster hemostasis, with excellent absorption in hemoglobin and oxyhemoglobin.

Features include easy-to-use procedure-based presets accessed via an intuitive navigation wheel or color touch screen, ultralight fiber and handpiece, innovative low-cost disposable tips, infinite pulse combinations which deliver laser energy by dose, and wireless foot pedal.

Jones added, "To our knowledge, this is the first commercialized dental laser offering a variety of procedure-based, single-use tips. The ezlase is based on an optimized, new 940nm laser system with pulse characteristics specifically engineered by BIOLASE to make more soft-tissue procedures minimally invasive, with improved clinical outcomes and increased patient comfort. The ezlase can comfortably be held in the palm of the dentist's hand."

FDA-cleared indications for the ezlase include incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival tissues and epithelial lining of free gingiva and numerous other specific indications for dental soft tissue procedures.

Additional FDA-cleared indications include laser periodontal procedures, including laser soft tissue curettage and laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket, and sulcular debridement.

BIOLASE plans to formally launch the ezlase laser system at the upcoming Chicago Dental Society mid-winter meeting in February 2007.

More information and images of the ezlase can be found via the Internet at