laser hair removel
Hello
I would like to ask if there is any specific requirements, r restriction or regulation to list IPL laser hair removal device on amazon.
Does I have to apply for FDA approval certificate?
If there is any, Can you put the link for this information.
Thank you
laser hair removel
Hello
I would like to ask if there is any specific requirements, r restriction or regulation to list IPL laser hair removal device on amazon.
Does I have to apply for FDA approval certificate?
If there is any, Can you put the link for this information.
Thank you
0 replies
Michelle_Amazon
Hello @Seller_zgjsrKfF4yyAJ,
Michelle at Amazon here. I understand that you would like to know if you need to apply for an FDA approval certificate for your IPL laser hair removal devices.
Laser hair removers fall under Class II and shall comply with the special controls issued by the FDA for assured safety and effectiveness of the device and shall obtain the 510(k) approval for importation and distribution of the device within the US market.. The FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on February 23, 2021, FDA issued an order to the requester classifying the device into class II.
You will then need to submit the 510(k) document to Amazon for review so that your listing can be reviewed. You can learn more on the requirements for medical devices here.
I hope this information has been helpful!
Wishing you the best!
Michelle
