Regulatory requirements for electrical cosmetic appliances

#1
Hi all

My company is developing a home use pilling/exfoliating electrical device.
while we are used to the regulatory requirements of medical devices, the field of non medical cosmetics is an uncharted territory to us.
We assume that as a non medical device, that it falls under the IEC60335 requirements but are unsure what (if any) path should we take to register the device in the FDA

Thanks for the help
 
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yodon

Staff member
Super Moderator
#2
Why do you think it's NOT a medical device? If, for example, it's a laser-based system for hair removal, the FDA indicates it'd be a class 2 device.

I don't know the answer to your question. I think typically, any home-use electrical (non-medical device) product would require UL listing for safety, at least.
 
#3
Thanks for the reply
We do indeed produce laser based systems and they are classified as class II under FDA regulations.
Our problem is with cosmetic devices that are not medical to our understanding like massagers, electrical pedicure devices Etc.
I could not find them in any medical device designation and doubt that they are even an exempt class I.
Hence our dilemma.
 

yodon

Staff member
Super Moderator
#4
I'd suggest engaging with a qualified regulatory consultant just to be sure. I'm not one but I could recommend someone. Send me a Private Message if you'd like some recommendations.
 

yodon

Staff member
Super Moderator
#5
Um, something is running on electricity if there are batteries. I presume you got some feedback of some sort from FDA? Can you post the specifics?

Whining and telling the FDA they're wrong is a bad strategy, indeed! :)
 

monoj mon

Involved In Discussions
#6
How do I satisfy Electrical Safety testing requirements when there really aren't any for battery operated devices? I don't know how to reply to the FDA except whine and tell them they are wrong; I hate to do that.
I am not sure why are you copying and pasting others comment everywhere! Do you really have any question! For example the above question was copied from this thread. I have seen you doing this in other threads also. By doing this you are wasting other's time who thinks you have some genuine question!

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