Biolux receives CE Mark for OrthoPulse

Biolux Research has announced that its OrthoPulse product has received the CE Mark and is now commercially available in all European countries that recognize the mark. The device is approved as a class 2A medical device via Medical Device Directive 93/42/EEC, Annex V by the London-based British Standards Institute.

The company also announced its new product website, www.orthopulse.com.

OrthoPulse utilizes photobiomodulation, or light therapy, to significantly reduce orthodontic treatment time, depending on treatment mechanics, patient compliance, and patient biology. The device uses low levels of near-infrared light energy to stimulate the periodontium and alveolar bone surrounding the roots of teeth to increase bone regeneration and turnover, thus accelerating tooth movement and dramatically reducing treatment time for braces or clear aligners, according to Biolux. Studies have also shown that tooth movement accelerated with OrthoPulse does not lead to increased root resorption, the company noted.