FDA Approved? Cleared?Updated a year ago

Here in Novaalab, all of our devices are FDA approved.

The difference?

FDA-approved means that the FDA has decided that the benefits of the product outweighs the known risks and the manufacturers have to submit a pre-market approval application as well as clinical testing results in order to get approved. FDA-cleared means that the manufacturer is able to demonstrate that the product is "substantially equivalent" to another similar legally market device that has already been approved.