Hello,

We are having trouble with our far infrared product being classified as a medical device. We have appealed multiple times and provided Amazon’s required exemption evidence, but they still require us to provide a 510(k) number

The deactivation reason is: 1. The product is identified as a high-frequency laser, LED, or other light therapy device for the treatment of acne, which is considered a medical device for professional use only.

2. They believe that the exemption evidence we provided does not include our product

I tried to ask customer service to help me look up the link trigger words, but nothing worked, and they said they didn’t know either. Now I have deleted the medical words I think may be in the description, but it still doesn’t work. Here is the information I have provided:

1. The FDA registration number of the device, showing that the product is classified as a 510k exempt device.

2. Provide pictures of the box and product manual

3. Confirmation letter from the manufacturer that the device is registered with the FDA as a Class I, 510k exempt device

Despite providing all this information, I received a response from Amazon, again requiring 510k clearance. I don't know how to further clarify that this is an exempt device, it is officially registered and does not require 510k clearance.

Here is our case ID: 16655505691

Requesting some pointers from experienced sellers. Can you guys help me with this? Many thanks

Thanks in advance,