FYI after talking to the FDA folks for a carrier it seems that the FDA/CDRH is pulling for inspection anything tagged "laser" from China to the USA.
They are busting a lot of items right now - just heard about 2000 pens with lasers in them which were caught a few days ago.
This means laser on the commercial invoice or laser in the name of the company shipping it.
So, a word to the wise - have your accession # information from your overseas supplier. This includes OEM parts since the CDRH now has a submission report for those as well.
Chuck - AixiZ