FDA approval or similar of Dectro epilators

Professionals Only! Electrologist to Electrologist (pros only)
#1

Hi all,

in order to deal with the upcomining regulations of electrolysis here in Germany i would like to know which epilators are approved as medical devices in Canada or the USA. Specifically, of course, my main machine, the Apilus Platinum Pure w. Synchro extension.

Background is
a) EU conformance
b) NISV relevance
For both situations i would like to know where i can obtain approval documents and which detailed technical specifications are documented for approval.

I am mostly interested in possible contact currents bot for RF an Galvanic, alternatively maximum RF currents (max galvanic current i specified in the user documentation)

Thanks in advance

#2

I definitely dont know any of that, and i would think the only source for that information would be Dectro in Quebec city.