Truth be told, I'm no lawyer, but to the best of my knowledge the above document will get a laser through customs.. Whatever legal mumbo-jumbo Wicked went through to prove that their device is worthy of an accession number I have no idea.
Based on what I have read to date, getting an accession number is easy (if you fill the form out right). The
IMPORTER (in this case whatever company WL is using) writes out a report showing how the new product conforms to the necessary regulations. If the form is filled out correctly, an accession number is issued. The FDA does not require physical samples to be submitted for testing.
Remember, the US legal system is based in English law (innocent until proven guilty). Now the importer can begin shipping units into the US. It is now left to the customs and the FDA to "catch" the importer shipping units into the US that do not conform to the report.
I am sure that the report that was used to obtain the accession number shows that the laser conforms. However, if a customs officer opens one and suspects that it does not conform, the unit is held for testing. If the units being imported do not conform to the report, the lasers will be confiscated and action can be taken against the importer.
If it is shown that this is not an isolated instance, there can be a notice sent out to hold all of the shipments.
I imagine, this is what is happening on the west coast now. Someone found that these lasers did not conform to what was in the report and the system is now grinding through the process. This is probably what got WL onto the prohibited list in the first place.
We would have to be able to read the report filed by WL to get the accession number to know if it was fraudulent or not.
They also still have the problem of WL's name being all over the interior packaging, the paperwork, and the laser itself.
Peace,
dave