Replies to post #299798 on BOUNCE (BOING)

[cintrix]

I don't know that much about this but I think the type of approval they got was not what they were looking for.

[cintrix]

I think I figured the ocul dump out - says designated the resubmission as a Class 2 review, - Look at the difference between the classes:

FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III. Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls.