Hello, laser beauty instrument belongs to the second kind of medical equipment. Products need to apply for medical device product registration certificate, and production and sales need to apply for relevant licenses. It is illegal for these things not to be done well. Equipment assembly and sales are within the scope of production, and medical device production license and medical device registration certificate are required.

What kinds of beauty instruments are there?

Nowadays, the types and functions of beauty instruments on the market are more and more complicated, and the quality is uneven. According to the product function series, it can be divided into three types. Beauty instruments are divided into three categories:

A, household instruments series:

This series of products are mainly used in the home field. Through the technical principles of radio frequency, light wave, micro current, steam and vibration, the beauty effect is achieved. Typical equipments include Tripollar, newa, nanoTime, refa, facial steamer, facial cleanser and so on.

Second, life beauty series:

Bio-line is a typical non-invasive beauty, which is mainly based on non-medical means such as cosmetics and health products and non-medical devices such as skin care and massage.

Third, medical beauty series:

Because the face is the key area for the use and maintenance of beauty instruments, it can be subdivided into face detection, cleansing and hydrating, and face anti-aging. Typical equipment includes intelligent magic mirror, small bubble, skin comprehensive management instrument, ultrasonic scalpel, hot Maggie and hot lati.

Medical devices are exported to the United States, but we don't have an FDA. Will there be any problems for customers to clear their imports in the United States? Is there a way to solve it?

If there is no FDA, beauty instruments will be detained by FDA when they pass customs. According to the use of products, beauty instruments can be divided into one or two categories. Beauty instruments belong to medical devices in the United States, and medical devices can only be exported after obtaining FDA. The FDA defines medical devices as: medical devices refer to instruments, equipment, appliances, machines, appliances, implants, in vitro reagents and other similar or related items, including parts or accessories, that meet the following conditions. It affects the structure and function of human body or other animals, and does not achieve its intended use through chemical reactions in human body or animals, nor does it rely on metabolic changes to achieve any of its intended uses. The FDA clearly stipulates the product classification and management requirements of each medical device. At present, there are more than 1700 kinds of * * in the FDA medical device product catalogue. For specific classification, please refer to the detailed description of the product. According to different risk levels, FDA classifies medical devices into three categories. The first category is "general management" products, which refer to products with little or no risk, accounting for about 25% of all medical devices. Class II products are "standardized management", which refer to products with certain risks, accounting for about 55% of all medical devices, and need to apply for 5 10k. Class III products are dangerous or harmful, or used to support life support, accounting for about 20% of all medical devices. Implement the "pre-listing approval" system.

What are the beauty medical devices in beauty salons?

There should be many. I have been to many beauty salons and many beauty instruments. Then I recommend which one to use if you need care. But now I go to the beauty salon regularly, and I also use ARPW to care for my face and body. This is a multifunctional beauty instrument, and the effect is really obvious.