Here we go! Sk-II!, page-58

The wand doodad could be considered a medical device under the definition in the Act because it modifies a physiological process.

Could be but it's not considered a medical device and not being sold as one, it's being sold as an applicator. Now that's not to say IF they were to start selling in Australia that the TGA couldn't ask them to respond but based on history and experience that is very unlikely. Regardless the important differentiation is that medicines and medical devices require TGA approval BEFORE you can start selling, the OBJ applicator can be sold straight away. Using the technology for pharmaceutical delivery now that's a totally different ball game as you're now talking about delivery into the blood stream.