Ann: Next Science Investor Presentation May 2019, page-39

To be clear, the FDA 510k clearances indicate two things:
1. That the products are safe
2. That they're similar enough to other products that supporting research or evidence doesn't need to be provided for assessment.

The approval process doesn't assess or validate the efficacy of the product or the quality of supporting evidence.

To make claims that a technology is substantially different in action or effectiveness would require a 'de novo' approval which is much harder and does require serious scrutiny of evidence and claims.