Biolase gains FDA clearance for calculi removal

Biolase Technology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Waterlase MD laser system for removal of subgingival calculi to prevent and treat periodontitis.

The Waterlase MD's patented Er:YSGG laser energy gently removes unwanted calculus deposits while preserving healthy tooth structure, according to Biolase. This offers long-term benefits for sufferers of periodontal disease because it controls inflammation and the disease without removing the healthy tissue required for regeneration and healing, the company said in a press release.

This new application of the Waterlase MD will enhance the company's deep pocket therapy with new attachment application, a minimally invasive alternative to traditional periodontal surgical treatment, Biolase noted.

"This not only enhances results in the hands of a periodontist using the Waterlase MD for regenerative procedures, it is also an alternative treatment for the general practitioner who is treating mild to moderate periodontal cases," said Mark Schlesinger, D.D.S., a periodontist in New York City, in the press release. "Patients are also more likely to accept the treatment when they hear that it is minimally invasive. Those who have had the treatment are getting positive results and avoiding the side effects that they have heard about from conventional treatment."