The legal aspects of opening and operating medical spas or nonsurgical centers comes up a lot.
In general it's up to individual states to decide what is or isn't a medical treatment and who can or can not operate medical devices. It's obvious from past history that medical device manufacturers would like to be deemed medical, but not operate as though they were. I guess spas and salons love to offer medical treatments. (Perhaps oversees it's not medical)
This comes directly from Palomar's web site on International Distribution Opportunities:
...seeking qualified international distributors for our laser/pulsed-light cosmetic devices into the doctor and spa/salon markets. To qualify, your organization must offer sales, service and marketing support. In addition you must have a presence in the medical and/or spa/salon markets.
I don't really blame Palomar for selling regulated devices into the third world. They're just trying to balance the trade deficit. Not really a criticism, just an observation.