Victoria BC—August 6, 2015—StarFish Medical, a Profit 500 medical device design and manufacturing company, today announced their client, Biolux Reasearch, received 510(k) marketing clearance for OrthoPulse™ from the US Food and Drug Administration on July 24, 2015.
OrthoPulse™ is a class II prescription medical device as regulated by the FDA, with 510(k) number K143120, and is intended for use during orthodontic treatment in conjunction with aligners or brackets and wires. OrthoPulse™ has already received regulatory approvals in the European Union, Canada, Australia, New Zealand, and other countries.
Kevin Strange, President and CEO at Biolux Research, notes, “The impressive clinical results and experience from our key evaluators and existing customers has been very encouraging; with significant acceleration of orthodontic treatment, we envision that OrthoPulse™ will be a game changer in the world of orthodontics. Patients and doctors want faster treatment and OrthoPulse™ can help them achieve their goals.”
“Working with StarFish has been really good. Their biggest advantage is that they have a formal product development process that ensures a good quality result.
StarFish has so many different services that you can be confident your project is being addressed comprehensively. We could not create these resources internally.
StarFish is a very fair and honest company. Their people are highly responsive and willing to go the extra mile. They do what they say they’re going to do and share the goal of a successful, long-term relationship.”
CEO, Biolux Research Ltd.
How StarFish Helped
- Tested and refined the design for a more ergonomic, aesthetic headset that facilitated a variety of facial geometries
- Developed electronic handset & operator interface
- Developed a heat management system
- Created protective disposables for the headset contact areas
- Supported a distributor through regulatory approval in Asia
- Detailed design & manufacturing transfer under ISO13485
- Provided ongoing manufacturing & sustaining engineering services
About Biolux Research
Biolux Research is a world leader in the development of innovative Light Accelerated Orthodontics™ technology and products for use in orthodontics, implantology, and other dentistry markets. Biolux Research focuses on product development and clinical research, and its proprietary, patent-pending technologies have been developed to enhance clinical outcomes and dramatically reduce treatment timelines in orthodontics and dentistry in a safe, effective and noninvasive approach. www.orthopulse.com www.bioluxresearch.com
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President and CEO