Was looking for this in the comments. The ambiguity there is abused by many companies on the fringes of consumer health and cosmetic products. > A 510(k) is a

Was looking for this in the comments. The ambiguity there is abused by many companies on the fringes of consumer health and cosmetic products. > A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval