We are beauty tools supplier in China with FDA approved

What is FDA?

Food and Drug Administration (Food and Drug Administration) referred to as FDA, FDA is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific management agency, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment and radiation products produced or imported in the United States. It was one of the first federal agencies whose primary function was to protect consumers. This institution touches the lives of every American citizen. Internationally, FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries seek and receive FDA assistance to promote and monitor the safety of their own products.

FDA certification in the traditional sense is not certification, but a kind of registration or registration:

1. FDA registration: Many products need to be registered when they are sold to the United States (such as food, medicine, medical equipment, laser products, etc.), and some products must be tested before they can apply for registration;

2. FDA testing: it is to test products in accordance with FDA regulations; Food and Drug Administration (FDA) supervisor: food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, alcohol content below 7 Supervision and inspection of % wine beverages and electronic products; testing, inspection and certification of ionic and non-ionizing radiation generated during the use or consumption of products that affect human health and safety. According to regulations, the above-mentioned products must be tested and proven safe by the FDA before they can be sold on the market. FDA has the right to inspect manufacturers and prosecute offenders. According to the different product ranges that are regulated, it can be divided into different regulatory agencies.

About FDA 510K approved

In order to market a medical device in the United States, a manufacturer must go through one of two evaluation processes: premarket notification [510(k)] (if not exempted by 510(k)), or premarket approval (PMA). Most medical devices for commercial distribution in the United States are approved through a premarket notification [510(k)]. In some cases, neither a 510(k) nor a PMA is required for a device legally marketed prior to May 28, 1976.

The 510(k) document is a pre-market application document submitted to the FDA. The purpose is to prove that the device applying for marketing is as safe and effective as the legally marketed device that is not affected by the pre-market approval (PMA), that is, an equivalent device (substantially equivalent). The applicant must compare the device applied for marketing with one or more similar devices currently on the US market, and draw and support the conclusion of an equivalent device. A legally marketed device is a preamendment device that was legally marketed before May 28, 1976, or a device that has been classified as a class II or I from a class III device, or has been found to be equivalent to such a device through the 510(k) process devices, or devices established through the evaluation of automated Class III device definitions. Equivalent devices are called "predicate device(s)". Applicants must submit descriptive data, and when necessary, performance data to show that the device is an equivalent device to the predicate device. Again, 510(k) data is data showing similarity, that is, the degree of equivalence between the new device and the predicate device.

Amazon pays more attention to product safety and compliance. For certain types of products, it requires sellers to provide relevant test reports and FDA registration numbers when putting products on the shelves. For this threshold requirement, many manufacturers and traders seem unable to cope.

Medical device FDA, US FDA divides medical devices into three grades: Class I, Class II, and Class III according to the level of risk. Class III has a high risk level. Most Class III products need to apply for PMA before going on the market, and the products need to undergo clinical trials. The products obtain PMA After obtaining the registration number, carry out enterprise registration and product listing, obtain the registration number, and then go on the market.

Our IPL Hair Removal Devices belong to Class II which also need 510K certificate.  

We are one of the few beauty devices suppliers with FDA 510K certification in China.

If you have any ideas to start beauty business on Amazon, we are your reliable choice.