Biolux Research, Vancouver, Canada, designer and developer of Light Accelerated Orthodontics™ technology and products, has received 510(k) marketing clearance for its OrthoPulse™ from the US Food and Drug Administration (FDA).
OrthoPulse is a class II prescription medical device regulated by the FDA and is intended for use during orthodontic treatment in conjunction with aligners or brackets and wires. The device’s 510(k) number is K143120.
The company has already received regulatory approvals for OrthoPulse in several countries including Canada, Australia, and New Zealand, and the European Union.
OrthoPulse uses low level light therapy, or photobiomodulation, to stimulate the periodontium and alveolar bone surrounding the roots of the teeth, which, according to the company, leads to accelerated tooth movement and reduced treatment time. The device can be used with either braces or clear aligners.
OrthoPulse is a one-size-fits-all silicone mouth guard that patients can use for self-treatment for 10 minutes a day at home. The device has accompanying native apps for iOS and Android platforms that the doctor and/or patient can use to track usage compliance.