Hi Ronen - Glad to be a new member of this forum; hoping to be a contributor soon. I've answered your questions below.
Is this new cleanroom intended for just that device?
Yes that is the intent at this moment of time.
is that an already-cleared device or a new one?
Yes it is a FDA cleared device
If a cleared one, what steps did you initially take to clear it?
Is the cleanroom going to be a new facility (separate location)?
Yes - adjacent building with new equipment.
If not, do you already have an equivalent cleanroom on the same site?
Yes, the current cleanroom is functional.
I am new to the FDA arena and hence the questions.