Quote by Anthony Youn

“A device can be considered FDA-cleared if the manufacturer and the FDA agree that it is very similar to another device already on the market and is deemed safe to use. Becoming FDA-approved is a more rigorous process, used for devices for which there aren’t other, similar approved models on the market. What makes it even more confusing is that some devices may be FDA-cleared for one indication but used and marketed by physicians for a completely different indication. For example, some devices may be FDA-cleared for pain reduction, yet plastic surgeons use them to reduce fat.”

Quote by Anthony Youn