If there is no FDA for cosmetic devices, there is a high probability that they will be detained by the FDA during customs clearance. The beauty equipment may be Class I or Class II depending on the use of the product. Beauty equipment in the United States belongs to the medical device, medical devices exported to the United States need to get the FDA before you can export. The FDA defines medical devices as follows: The so-called medical devices are instruments, equipment, apparatus, machines, appliances, implants, in vitro reagents, and other similar or related items, including parts or accessories, that meet the following conditions. Affect the structure and function of the human body or other animals, and not through chemical reactions in the human body or animals to achieve the established intended use, nor rely on the production of metabolic changes to obtain any of its established intended use.FDA for each type of medical device are clearly specified in the product classification and management requirements, the current FDA medical device product catalog*** there are more than 1,700 kinds of specific how to divide, need to Refer to the product's detailed specification. According to the different risk levels, the FDA will be divided into three classes of medical devices (Ⅰ, Ⅱ, Ⅲ), class I for "general management" products, refers to the risk of small or basically non-hazardous products, accounting for about 25% of all medical device varieties. Class II is the "Executive Standard Management" products, refers to the products with a certain degree of danger, accounting for about 55% of all medical device varieties, need to apply for 510k. Class III is a greater danger or hazard, or used to support the maintenance of life of the products, accounting for about 20% of all medical device varieties. The implementation of the "pre-market approval" (PMA) system.