Biolux Research Announces Product Approval in Australia and New Zealand

Posted: March 9, 2015
Edited by Orthotown staff

VANCOUVER—Biolux Research, designer and developer of Light Accelerated Orthodontics technology and products,has announced that OrthoPulse, has received two new regulatory approvals.

These most recent approvals, in Australia and New Zealand, will enable doctors in those countries to offer this acceleration technology to their orthodontic patients. 

The OrthoPulse device is used as an easy self-treatment by the patient for a short 10 minutes per day. OrthoPulse utilizes low level light therapy, or photobiomodulation, to stimulate the periodontium and alveolar bone surrounding the roots of the teeth to significantly increase tooth movement and dramatically reduce treatment time for braces or clear aligners. Reducing the time required for orthodontic treatment can also help to prevent decalcification and gingival recession.

In Australia, OrthoPulse is now approved by the Therapeutic Goods Administration (TGA), Certificate Number: DV-2014-MC-20559-1, in the product category of Medical Device Class IIa. The TGA safeguards and enhances the health of the Australian community through effective and timely regulation, and by continually monitoring and evaluating the safety and performance of therapeutic products.  

In New Zealand, OrthoPulse was approved by the Medicines and Medical Devices Safety Authority (Medsafe) as a Class IIa product under WAND, Reference Number: 150122-WAND-6J4TXS. Medsafe’s mission is to “enhance the health of New Zealanders by regulating medicines and medical devices to maximize safety and benefit.” 

“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. 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. Long orthodontic treatment timelines are one of the top concerns for all orthodontic patients, and we feel that our solution will dramatically change the orthodontic market for patients, doctors, and the industry," said Kevin Strange, president and CEO of Biolux Research.
 

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