Over the last 2 to 3 years the FDA has become much tougher in approving new devices. One area of particular concern for approval of the Zeltiq-cool sculpting device was: does it effect cholesterol levels. The FDA said it fortunately has no effect on cholesterol levels. Of coarse, with all new technologies doctors and patients should remain vigilant for any u expected untoward responses.
Web reference: http://www.advanceddermatologypc.com/cosmetic/zeltiq.html