I recently created a listing for my product. Unfortunately, the listing was deactivated, claiming a restricted product policy violation. It appears that a term used in the item description triggered the violation, and I was asked to provide invoices, product images, and an FDA 510k number.

Stated reason for deactivation was: This product has been identified as a high-frequency laser, LED, or other light therapy device marketed to treat acne, which is considered a professional-use only medical device.

I submitted all the requested documentation, and everything seemed to be in order except for the 510k number. The Amazon team continues to request a 510k clearance for this device, but I’ve been trying to explain that it is a Class I device that is 510k exempt. Here's what I’ve already provided:

1. FDA registration number for the device, clearly showing that it’s registered under product code ISA (massager), classified as a Class I device that is 510k exempt.

2. A link to the FDA website, where it is evident that this device is regulated under 21 CFR 890.5660.

3. A confirmation letter from the manufacturer verifying 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 requesting the 510k clearance. I am at a loss on how to further clarify that this is a Class I device, officially registered as such, and does not require 510k clearance.

I would really appreciate your help in escalating this issue. Case number 16504972341. ASIN B0DK4T9HL7

@Glenn_Amazon , @Manny_Amazon

I noticed that you have successfully assisted other sellers with similar issues. Would either of you be able to help me resolve this situation?

Thank you so much for your support.