Dr Ross Walker interviews Dr Wayne Markman on Light Therapy and Parkinson's

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SYMBYX medical laser devices are CE- and ARTG listed. SYMBYX devices are subject to different regulations, permits and clearances in each country and are not available for sale in all countries, including the U.S.
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[@sallyleitner1999]

How is the unit charged? What voltages and amps in volved in unit?

[@symbyxbiome]

The unit is charged using a rechargeable battery pack plugged into the wall. You can find out technical information on the helmet by visiting or website www.symbyxbiome.com or emailing [e-mail].

[@carlmclean5076]

what study has been launched with the FDA? I looked and nothing is there. Is this a fraud or let me know the study?

[@symbyxbiome]

Dear Carl, thanks for your interest. No, we are not fraudulent - we have regulatory clearances throughout Europe/UK, parts of Asia and Australia/NZ. This means we have demonstrated both safety and efficacy through peer-reviewed clinical trials. The US FDA, as you know, sets its own rules and procedures for medical devices sold in the US market. We are currently in discussions with them but have not "launched" a US study. While there is no requirement to complete a study in the US, we are very mindful of the need to complete clinical trials that would be acceptable to FDA. We hope this clears up any confusion or incorrect expectation that you might have. Best regards. The SYMBYX Biome Team

[@carlmclean5076]

@@symbyxbiome Can you direct me to the Europe Clinical Trial website so I can review the medical device clinical trial that was completed?

[@carlmclean5076]

Can I get a copy of the submission to the Europe/UK study

[@carlmclean5076]

@@symbyxbiome can I see the submission to the Europe/UK study?

[@symbyxbiome]

@@carlmclean5076 Hi Carl, our research can be found on our website at www.symbyxbiome.com. It was completed in Australia. It was this research that allowed for medical clearances in Europe/UK. Hope this helps!