EF-
as bitter as i am to all of this, it isnt as bad as youre making it out to be.
This is technically a "self certifying" profession. In other words, you can make your laser in a toaster over with 500 watts of IR leakage and a cardboard optical table and get an accession # from your product report. At this point, in the eyes of the CDRH, you are using a compliant projector. (obviously in your report, you wouldnat have said you made all of those bonehead designs). This is why all of these chinese companies that say FDA comliant are full of poopie. Anyone can submit a report for anything and make it look good and get an accession # for it. an accession # is NOT an approval.
Now, on the "approval" term. Product reports are no longer "approved." you submit your report, tell them how you designed and built your system, and it is your responsibility to make sure the projector is built to those specifications in your report.
As long as you build your system with the required safety features, CDRH will have no objections and you will never hear from them again.
Once you submit your paperwork, and get you ack letter and/or accession # you're good to go.
Casey Stack confirmed the above statememt at SELEM also!
-Marc