(For US readers)
I'm excruciatingly familiar with the twists-and-turns of all the "esthetician units" that treat skin lesions. All of the dedicated units are re-labeled thermolysis units that are being used "off label."
Were any company to claim their dedicated unit was anything other than an electrolysis unit (and already certified as such), they would have to present evidence of this being something new. Thus, they would have to spend many thousands of dollars for an FDA test. If they claim the unit is equivalent to, say, the Hyfrecator or Bovie (both medical devices), then the unit could only be sold (after testing) to medical doctors. So you see, it's a "catch 22."
If you directly ask any of the "dedicated unit" sellers, they are going to give you a bunch of baloney. So far, no agency has made much ado about this little issue ... however, one good fat lawsuit and that will bring all of this crashing down. The fat lawsuit will probably have something to do with a non-medical person removing a skin cancer and the patient not seeking timely treatment ... with bad results.