Hello, laser cosmetic equipment belongs to the second class of medical devices, the product is required to apply for a medical device product registration certificate, production and sales need to apply for the relevant license. Not to do a good job of these are illegal. For assembly and sales of this aspect of the equipment, is the scope of production, so you need to apply for a medical device production license and medical device registration certificate.
Beauty equipment is divided into those categories
The types of beauty equipment on the market now function more and more complicated, the quality also varies. According to the product function series can be divided into three kinds. Beauty equipment is divided into three categories:
One, home instrument series:
The products of this series are mainly in the field of household, through radio frequency, light wave, micro-current, steam, vibration and other technical principles, to achieve the effect of cosmetic, the typical equipment are: Tripollar, newa, nanoTime, refa, face steamer, facial cleansing instrument and other equipment.
Two, life beauty series:
The main use of cosmetics, health care products and non-medical devices and other non-medical means of human skin care, massage and other non-invasive beauty care with maintenance or health care, the more typical representative is bioline.
Three, medical beauty series:
Because the face is the key area of the beauty instrument Use and maintenance of the key areas, so can be subdivided into facial detection, cleaning and hydration and face anti-aging. Typical devices include intelligent magic mirror, small air bubbles, integrated skin management instrument, ultrasonic knife, Thermage and Thermal Lift.
Export to the United States medical devices, but we do not have FDA, customers in the United States import customs clearance will have problems, there are ways to solve it
If the beauty equipment does not have FDA, the probability of customs clearance in the FDA will be detained. Cosmetic devices 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 classify, need to Refer to the product's detailed specification. According to the different risk levels, the FDA will be divided into three categories of medical devices, 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 products with a certain degree of danger, accounting for about 55% of all medical device varieties, need to apply for 510k. Class III is more dangerous or hazardous, or used to support the maintenance of life of the product, accounting for about 20% of all medical device varieties. The implementation of "pre-market approval" system.
What are the beauty medical devices for beauty salons?
There should be a lot of it, I've been to a lot of beauty salons are a lot of beauty equipment, and then you need to which aspect of the care will recommend you use which one. But now I fixed to go to a beauty salon, but also fixed to use ARPW ARPW to face and body care, this is a multi-functional beauty equipment, the effect is also really greatly obvious.