Assistance Needed: Product Misclassification Issue
Hello,
I'm facing challenges listing my product, the "7-in-1 LED Light Therapy For Face and Neck," (ASIN- B0CQKLGXDB) due to its incorrect categorization as an ultrasound/ultrasonic device and a medical-use product.
Consequently, I've been requested to provide FDA 510K certification. I want to clarify that our product is exclusively designed for beauty purposes. It doesn't employ ultrasound or ultrasonic technology and is not categorized as a professional-use only medical device.
Our focus lies in LED light therapy, micro-current anti-aging technology, and skin tightening – all aimed at enhancing skin health and beauty. Recognizing the importance of compliance, we want to assure you that our product aligns with the intended use for consumer beauty and skincare. If anyone has encountered a similar situation, your assistance would be greatly appreciated.
Thank you for your help.
Best regards,
Vortex Supplies
Assistance Needed: Product Misclassification Issue
Hello,
I'm facing challenges listing my product, the "7-in-1 LED Light Therapy For Face and Neck," (ASIN- B0CQKLGXDB) due to its incorrect categorization as an ultrasound/ultrasonic device and a medical-use product.
Consequently, I've been requested to provide FDA 510K certification. I want to clarify that our product is exclusively designed for beauty purposes. It doesn't employ ultrasound or ultrasonic technology and is not categorized as a professional-use only medical device.
Our focus lies in LED light therapy, micro-current anti-aging technology, and skin tightening – all aimed at enhancing skin health and beauty. Recognizing the importance of compliance, we want to assure you that our product aligns with the intended use for consumer beauty and skincare. If anyone has encountered a similar situation, your assistance would be greatly appreciated.
Thank you for your help.
Best regards,
Vortex Supplies
2 replies
Webb_Amazon
Hello @Seller_vXuH9IxJ0597l.
Thank you for reaching out to the seller forums.
I understand that you are facing these issues with the product you are listing. When a product is identified as an ultrasound/ultrasonic device and a medical-use product, this usually means that the product has been identified as a restricted product and certain verbiages in the product detail page can flag the product to be restricted as well.
Do you have any violations on your account health dash board?
When you listed this product, did you list it in the correct category?
Do you have supporting documents that shows proof that the product is not a medical device or associated with ultrasonic technology, and is compliant with our policies and or exempt from submitting the 510K certification?
These are some factors you want to look into and also identify the verbiages to see what is flagging the products to be a medical device.
Best,
Webb
