; its use on the surface of the human body and in the body is not obtained by pharmacological, immunological or metabolic means, but may have the participation of these means and plays a certain auxiliary role; and its use is intended to achieve the following intended purposes: (i) the prevention, diagnosis, treatment, monitoring, and alleviation of disease; (ii) the diagnosis, treatment, monitoring, alleviation, and compensation of injury or disability; (iii) the study, substitution, and regulation of anatomical or physiological processes; and (iv) the control of pregnancy.
So it is not acting on the human body, it is not a medical device.