I believe they’ve started the process however haven’t filed the full document stack. Unlike the drug FDA approval path where you have to get permissions to start phased clinicals, equipment that is already deemed safe and legal to use on the general public has a much simpler route. In this case the independent clinical trials are typically submitted with the application. If the FDA finds that the clinical trials are inconclusive they may ask for more trials. I think CIRT would be smart enough to make claims that are unarguable fact like cellulite melts away when using the product. Something that the clinicals would have been conclusive on… not something like it cures cancer. Making an approval attainable fairly quickly.
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