Before purchasing, I contacted merchant to assure unit was FDA approved. I was assured it was and was given a link to the FDA website for registration. The unit came promptly and when I opened it, there was no FDA Approval Sticker on it. Nor did it have a label stating it was a radiation emitting device as required by FL law. After multiple correspondence with manufacturer and the FL Dept. of Health, it was determined to be FDA approved, but the manufacturer had to provide an appropriate label for the machine. I'm currently waiting to use the unit, as I've not yet received that label from the manufacturer.
Cannot assess it function for I've not energized it yet due to labeling deficiencies.
Update:
As promised, manufacturer did get me the label in a timely fashion, and after using it now for two days, the unit is producing nice images--overall, I'm please and my hygienist likes the unit. Just wished it was appropriately labeled out of the box for use here in Florida.
For the money, its been great.