FCC Certification for RF Microneedling Device

margadia

Involved In Discussions
Hello. The organization I work for is considering taking on an RF microneedling device. I know as far as FDA clearance, the product does not require FCC certification, but to import and market the device in the US, would an RF microneedling laser require FCC certification? I don't see any of the predicate devices with FCC certification, but it appears from reading the testing and compliance requirements, that such a device would be an intentional radiator and therefore, would require certification. Is this accurate? Would this follow Part 18 as it is a medical device? Any information is appreciated.
 

emceng

Starting to get Involved
I'm not familiar with RF microneedling tech, but from a quick look online it seems like it uses RF to do something with the skin. Assuming it isn't using RF for communication like Wifi or Bluetooth then Part 18 would be appropriate.
 

margadia

Involved In Discussions
I'm not familiar with RF microneedling tech, but from a quick look online it seems like it uses RF to do something with the skin. Assuming it isn't using RF for communication like Wifi or Bluetooth then Part 18 would be appropriate.
thank you for your feedback!
 
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