Are endermologie devices medical devices?
Yes. The FDA stated in a letter to the manufacturer of endermologie devices: Under a United States Federal law, the Federal Food, Drug, and Cosmetic Act, the ES 1 [endermologie machine] is considered to be a medical device because it is being used to diagnose or treat a medical condition or to affect the structure or function of the body. The FDAs complete definition of a medical device can be found here: http://www.fda.gov/cdrh/devadvice/312.html.
