Listing removed because amazon considers the LED Therapy Device as a lazer or medical device!
I recently received an email from Amazon regarding my listing for a LED face Therapy Device. Unfortunately, neither I nor my supplier possess the 510K number issued by the FDA. Although numerous listings for this product exist on Amazon, I am encountering this issue. The listing was live for an entire day, and I invested significantly in inventory. Given the high cost of this product, I am uncertain about the next steps to take.
This has been identified as a laser, LED or other light therapy device marketed to treat acne, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page (https://sellercentral.amazon.com/gp/help/external/help.html?itemID=200164650&language=en-US&ref=efph_200164650_cont_200164330) and the following FDA guidance:
Listing removed because amazon considers the LED Therapy Device as a lazer or medical device!
I recently received an email from Amazon regarding my listing for a LED face Therapy Device. Unfortunately, neither I nor my supplier possess the 510K number issued by the FDA. Although numerous listings for this product exist on Amazon, I am encountering this issue. The listing was live for an entire day, and I invested significantly in inventory. Given the high cost of this product, I am uncertain about the next steps to take.
This has been identified as a laser, LED or other light therapy device marketed to treat acne, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page (https://sellercentral.amazon.com/gp/help/external/help.html?itemID=200164650&language=en-US&ref=efph_200164650_cont_200164330) and the following FDA guidance:
0 respuestas
Seller_LVZcgxAgZ2xBv
Some of your competitors have gotten a 510k number from the FDA, and there is a classification for such OTC devices ("Light Based Over The Counter Wrinkle Reduction") for the FDA regulation "Laser surgical instrument for use in general and plastic surgery and in dermatology."
You can search the FDA 510k database to see the other companies that have done this successfully, as well as the relevant classifications and standards.
Cooper_Amazon
Good Evening @Seller_J6o4ddxTYFlCn, I can definitely look into this feedback that the team has been providing you regarding needing a 510k number. Can you please provide me with the case ID you have been working on with the Seller Support team? Looking forward to speaking with you soon. Sincerely, Cooper_Amazon
