Biolux Research announced that OrthoPulse has received regulatory clearance in Australia and has been registered in New Zealand.
Kevin Strange, president and CEO of Biolux, stated in a press release that his company was pleased with the regulatory approval.
"We are excited about bringing the benefits of OrthoPulse to patients and dental professionals in Australia and New Zealand. OrthoPulse has already received regulatory approval in Europe and Canada," he said. "We look forward to receiving more approvals in other countries in the near future as we expand the introduction of this revolutionary product to the worldwide orthodontic market."
In Australia, OrthoPulse has been certified by the Department of Health's Therapeutic Goods Administration (TGA) as a medical device class IIa. In New Zealand, OrthoPulse was registered by the Medicines and Medical Devices Safety Authority (Medsafe) as a class IIa product in the Web Assisted Notification of Devices (WAND) database.
OrthoPulse utilizes photobiomodulation, or light therapy, to significantly reduce orthodontic treatment time. It uses low levels of near infrared light energy to stimulate the periodontium and alveolar bone surrounding the roots of the teeth to significantly increase bone regeneration and turnover, thus accelerating tooth movement and dramatically reducing treatment time for braces or clear aligners, according to the company.
