Hi there @Seller_bQIgvYHFevbyh,

Thank you for reaching out with your concerns with your appeal to get your product reinstated. For this product, it has been identified as a microneedling skin roller or similar product that is considered a medical device due to either (1) the product’s technical characteristics, as the product’s needle length is greater than 0.3 mm, (2) the inclusion of medical marketing claims in the product details and/or images, or (3) a combination of both technical characteristics and marketing claims.

If you are looking to get this product reinstated you will need to provide documentation that demonstrates that this product is not a Medical Device. Only microneedling skin rollers that cannot be considered medical devices, or microneedling skin rollers that have received FDA clearance for over-the-counter sale, are allowed to be listed or sold on Amazon.

From your case I can see that the team is requesting photos of the instructions for this product and the 510(k) number issued by the United States Food and Drug Administration (FDA) for this product. If the product does not have a 510(k) you will need to provide an explanation along with proof to support the 510(K) claim exemption.

Please continue to work with the appeals team in your case and provide them with the information they are requesting. Thank you for your understanding.

-Glenn