ELAD,

FDA approval is much more about safety than efficacy. The process where the FDA approves new medical devices is MUCH DIFFERENT (way less) from the for new drugs.

Most devices are approved using the so-called 510(k) process. In simple terms, if there’s an existing device that is pretty similar to the new device, and the old device is safe, then the FDA will clear the new one, too. If they are different, the FDA will make a new category. But they don’t test the devices for effectiveness. And that is a big problem.

If you look at the letter from the FDA there’s nothing in it about whether or not the laser works at all, ie how well the Zerona actually melt fat. The letter is all device classification. Being safe is NOT the same as being effective. Read the FDA approval letter, then ask your self the same questions.

MS
5-27-11