I recommend LSX from dr.lava as far as software goes.
http://hacylon.case.edu/ebay/laser_diode/LSX.php
On the FDA standpoint, the way it works, in a nutshell, is this; You submit your product design, etc, and your application to the FDA and they give you an accession number. Your then allowed to sell your product once you receive your accession number, however, you are required to keep records each and every product sold. When the FDA actually gets around to reviewing your application an product in detail, and they find something they don't like about it, or if what your selling doesn't match what was submitted, you get a notice of non-compliance.. If you get one of those, you have to do everything in your power to recall and fix each and every laser device you sold under that accession number and correct the deficiencies they found. If you don't, the accession number gets pulled.
Like I said. if you never hear from the FDA after you get your accession number, that's pretty much an approval. You only hear from them when there's a problem.
Also, since accession numbers are by product.. and not by company.. An easy way to find out if a chinese company (or anyone else) is lying about having gone through the process is to ask for the accession numbers for two vastly different laser products they sell. If they give you the same number for both.. they're lying.
It's not really hard to get an accession number. However the costs if a problem is found mount up drastically.. which is why you have to make sure your ducks are in a row on the front end.. which is the real hard part of getting an accession number. And why most chinese sellers don't actually have one, or have one for a limited time until they get notified of non-compliance and do nothing about it and get the number pulled.