Replies to post #30188 on Bioelectronics Corp (BIEL)

[kidnova]

I'm on my phone so I'm going to keep it short. Their device is not considered thermal right now. It's still ILX but their petition tried to argue it should be IMJ and OTC. My point is that they should have been arguing for class II for ILX devices since they don't know if their IMJ reclass appeal will be approved or not. They missed an opportunity is all.

Also I think you misread the summary as the FDA is recommending class II with special controls for all ILX devices. Whether or not the panel agrees is yet to be seen.