Is laser beauty equipment a medical device?

Hello, laser beauty equipment is a Class II medical device. The product requires a medical device product registration certificate, and relevant licenses are required for production and sales. Failure to do this is illegal. Assembling and selling equipment falls within the scope of production, so you need to apply for a medical device production license and a medical device registration certificate.

What are the categories of beauty equipment?

The types of beauty equipment on the market are becoming more and more complex, and their quality is also uneven. According to the product function series, it can be divided into three types. Beauty instruments are divided into three categories:

1. Household instrument series:

This series of products are mainly for household use, using radio frequency, light waves, microcurrent, steam, vibration, etc. Technical principles to achieve beauty effects, typical equipment include: Tripollar, newa, nanoTime, refa, facial steamer, facial cleanser and other equipment.

2. Lifestyle beauty series:

Mainly use non-medical means such as cosmetics, health products and non-medical devices to perform skin care, massage, etc. on the human body with maintenance or health care A typical representative of non-invasive beauty care is bioline.

3. Medical Beauty Series:

Because the face is the key area for the use and maintenance of beauty equipment, it can be further subdivided into facial detection, cleansing and moisturizing, and facial anti-aging. Typical equipment includes smart magic mirrors, small bubbles, comprehensive skin management devices, ultrasonic scalpels, Thermage and thermal lift.

Exporting medical devices to the United States, but we do not have FDA. Will customers have problems with customs clearance when importing into the United States? Is there a way to solve it?

If beauty equipment does not have FDA, it will be a big problem during customs clearance. There is a chance it will be detained by the FDA. Beauty equipment may be Category I or Category II depending on the use of the product. Beauty instruments are classified as medical devices in the United States. Medical devices exported to the United States must obtain the FDA before they can be exported. The US FDA defines medical devices as follows: Medical devices refer to instruments, equipment, appliances, machines, appliances, implants, in vitro reagents and other similar or related items that meet the following conditions, including parts or accessories. Affects the structural function of the human body or other animals, and does not achieve its intended intended use through chemical reactions in the human body or other animals, nor does it rely on metabolic changes to achieve any of its intended intended uses. The FDA clearly stipulates its product classification and management requirements for each type of medical device. Currently, there are more than 1,700 types in the FDA medical device product catalog. For specific classification, you need to refer to the detailed instructions of the product. According to different risk levels, FDA divides medical devices into three categories. Category I is "general management" products, which refers to products with little or no risk, accounting for about 25% of all medical device varieties. Category II is "standard management" products, which refers to products with certain risks, accounting for about 55% of all medical device varieties, and needs to apply for 510k. Category III is a product that is highly dangerous or harmful, or is used to support and maintain life, accounting for about 20% of all medical device varieties. Implement a “pre-market approval” system.

What are the beauty medical equipment in beauty salons?

There should be many. I have been to many beauty salons and they all have a lot of beauty equipment, and I will recommend you which one to use according to the type of care you need. But now I regularly go to a beauty salon and use ARPW to care for my face and body. This is a multi-functional beauty instrument, and the effect is indeed very obvious.