Home RF beauty instrument collective "dumb fire"

Yangcheng Evening News reporter Wu Shan

"On March 29, I saw Yameng's beauty device in Sam's Supermarket in Tianhe, why was it taken off the shelves on the evening of March 31?" Ms. Huang, a consumer in Guangzhou, told a reporter from Yangcheng Evening News that this star product of Yameng cannot be seen online and offline in Sam's Club. The reporter learned that not only Sam, but also the official stores of major brands of household RF beauty instruments rushed to remove the products from the shelves before the "node" on April 1. The beauty artifact that was once popular all over the Internet and was praised by major beauty bloggers suddenly became "dumb fire", and its root cause is mainly related to the strong regulatory policy of radio frequency beauty instruments.

In short, from April 1, RF beauty instrument products should be managed in accordance with the third class of medical devices, and "certified work". According to industry insiders, the home radio frequency beauty device will be re-launched after obtaining the certificate, and it will be the end of the year at the earliest. Some consumers bluntly said that in the face of these incomprehensible "black technologies", after setting a high threshold, they may no longer have to pay for the "IQ tax" in the future.

Endangering personal safety

In the eyes of merchants, the home radio frequency beauty device market is a piece of fat. Based on the data of last year's "Double 11" major e-commerce platforms, the sales volume of brands such as Miguang, Yameng, Huazhi, and Jimeng ranked among the best. According to the sales statistics of Tmall and Taobao beauty devices in the first nine months of 2023, the highest market share is Miguang, with sales of 1.076 billion yuan and a market share of 11.04%. Yameng followed, and its sales also exceeded 1 billion yuan. Based on this calculation, with only the beauty instrument, the annual sales of Miguang and Yameng exceed 1.2 billion yuan.

When it comes to radio frequency beauty devices, Ms. Shanwei Lin told a reporter from Yangcheng Evening News that this kind of beauty device should have been well managed a long time ago. Spending thousands of yuan to buy a big-name beauty device not only did not have the effects of lifting and firming, reducing wrinkles and other effects as advertised, but instead sent her to the hospital emergency room.

In February this year, she spent nearly 2,000 yuan to buy a radio frequency beauty device through the official flagship store of AMIRO in the China Merchants Credit Card Mall. As a result, it only took five uses before something went wrong. "From the time I received the goods, the first time I used the neck mask, the second time I used the mask, the third time I used the mask, the fourth time I used the mask, and the accident happened until the fifth time I used the eye mask and gel. Ms. Lin said she felt an electric current pull into her face's nerves. "At that time, I was speechless. The area around his eyes was black and bloodshot, and he was immediately taken to the hospital for emergency treatment." Ms. Lin said that afterwards, she asked Miguang customer service for an explanation, but was accused of being a one-sided statement rather than a product problem, and said that it had exceeded the 7-day return period without reason, and the product could not be returned and could only be returned to the factory for testing. "My life is almost gone, even if I get a new one if I am detected with a problem, do I still dare to use it?" Ms. Lin said, she followed the manipulation process from low-grade to high-end step by step, and something happened when using high-end.

Through the black cat complaint platform to query the keyword "beauty instrument", there are more than 2,000 related complaints. In addition to complaints about the ineffectiveness and exaggerated publicity of RF beauty devices, safety issues that endanger personal health have become the focus of complaints.

A number of users have complained that the merchant has not fulfilled its obligation to inform the problem that thyroid patients cannot use the RF beauty device. According to a complainant, in July last year, she spent more than 4,000 yuan on Taobao platform to buy a Miguang RF beauty device. In September, it was learned that patients with thyroid nodules could not use beauty devices in the new product welfare group of Miguang. Later, the customer service also admitted that the use of thyroid nodules by patients with thyroid nodules would affect the body. The user emphasized that there was no clear indication in the product manual of this beauty device, and the merchant did not clearly indicate that it could not be used by thyroid patients when purchasing.

The customer service argues that the instructions have a warning that "immune system disorders" are not recommended for users. However, in this user's opinion, it is difficult for ordinary users to make a clear judgment on "immune system disease". "When I registered at the hospital, I saw an endocrinology department for thyroid nodules. ”

It is understood that there is an overlap between the group of thyroid problems and the group of female users of "anti-premature aging". This issue is of particular concern when the thyroid nodule (ultrasound) has a high detection rate. According to the data from the National Iodine Nutrition Survey and Research, the detection rate of thyroid nodules in China is about 20%. Lin Jiabao, attending physician of the Department of General Surgery of Nanfang Hospital of Southern Medical University, said that radiofrequency beauty devices cannot be used for thyroid diseases, generally because they may cause aggravation of the condition after use.

Beauty blogger Chen Linlin revealed to reporters that not only the thyroid problem, but also the question of whether the RF beauty device can be used for moles and spots, the business's expression is also vague. On the product page of a big-name RF beauty instrument with good sales, the reporter saw a full of efficacy publicity. As an ordinary consumer, not only can you not accurately judge the authenticity of the effect, but you also have no way to understand the technical terms such as microcurrent, wavelength, and waveform mentioned in it. However, as for the "risk" issue related to the vital interests of consumers, the merchant did not mention it.

"Even if you ask customer service, the statement will be different. It is a field of specialization that involves a lot of medical knowledge. Chen Linlin said that the implementation of the new regulations has given the RF beauty device a high threshold, and it has helped consumers check in terms of safety and effectiveness, which is worthy of praise.

It's hard to see in a brick-and-mortar store

On April 1, the reporter visited the Guangzhou market as a consumer. Surprisingly, these RF beauty devices, which cost thousands of yuan per customer, can hardly find physical stores in the Guangzhou market. As a beauty device product with a great sense of experience, it is really puzzling that consumers can easily pay for it just by relying on online publicity.

After several searches, the reporter found a Yameng store on the second floor of Tianhuan Plaza. The store is very small, only a few square meters, and the location is also very unremarkable, which does not seem to match the advertised image of a high-end Japanese beauty device. There are only a few products in the store. The clerk told reporters that Ms. Huang had seen the Yameng RF beauty instrument in Sam's Club, the store had been taken off the shelves, and the store was now promoting a beauty instrument with an all-in-one function of more than 7,000 yuan after discount, and it was not clear whether it would be re-listed in the future. As for the Miguang, Huazhi, and Jimeng brands, the reporter has not seen a physical store in the Guangzhou market for the time being.

In terms of online shopping channels, the Xiaohongshu platform issued the "Notice on the Adjustment of Radio Frequency Beauty Equipment Products" on March 29, and platforms such as JD.com and Tmall also issued a notice to brand merchants that "no license will be allowed to be sold after April 1". The reporter checked and found that at present, the official flagship stores of major brands have removed their own radio frequency instrument beauty-related products from the shelves.

In some personal online stores, dealer stores and second-hand platforms, you can still see the new RF beauty device for sale. ×× the customer service of the international trade selection store said that although the flower to radio frequency beauty device sold in the store can be successfully ordered, it cannot be shipped, and it is necessary to wait for the manufacturer's notice. When communicating with the customer service of Huazhi's official flagship store, the other party said that because this product (a radio frequency beauty device that has been removed from the shelves) is currently adjusting the page information according to relevant regulations and policy requirements, if you want to know more about the functional selling points of this product, you need to enter the line after April 10.

Not a "Category III" registration

The reporter combed and found that in response to the chaos of radio frequency beauty instruments, the relevant state departments continuously released signals of strong supervision. In the "Announcement on Adjusting Part of the Classification Catalogue of Medical Devices" issued by the State Food and Drug Administration in March 2022, it is clarified that radiofrequency therapy devices and radiofrequency skin therapy devices are managed in accordance with Class III medical devices. From April 1, 2024, such products shall not be produced, imported and sold without obtaining a medical device registration certificate in accordance with the law.

In April 2023, the State Food and Drug Administration issued the "Guiding Principles for the Registration and Review of Radio Frequency Beauty Devices", which clarified that handheld (small) radio frequency beauty devices are within the scope of supervision, and required that radio frequency beauty devices need to carry out clinical evaluation according to the requirements, once again showing a signal of strong supervision.

It is understood that the third class of medical devices refers to medical devices that are potentially dangerous to the human body and need to be strictly controlled for safety and effectiveness. Among the first, second and third class medical devices, the third category is also the highest risk, such as artificial heart valves belong to the third category.

The reporter inquired through the official website of the State Drug Administration, and only found a variety of "third-class" radiofrequency therapy devices used to reduce skin wrinkles, treat atrophic acne scars, and improve facial skin laxity in the registration information of imported medical devices. Among them, no information on the current hot-selling household radio frequency beauty device brands and related enterprises was found. Judging from the registration information, these radiofrequency therapy devices are commonly used in medical institutions.

According to the staff of a medical device manufacturer in Guangdong, the registration cycle of medical devices is long, from the establishment of GMP system, product testing, animal testing, clinical trials, successful registration declaration, and then to obtain the registration certificate of Class III medical devices and medical device production licenses, it takes at least two years, and the registration input cost is at least 5 million yuan. Clinical trials, in particular, often take 12 to 24 months.

He said that taking the relatively mature skin booster as an example, the registration process for Class III medical devices will take about two and a half years at the earliest, and there is no precedent for the registration of household RF beauty devices, so it is expected that the situation will be more complicated and the whole process will take longer. He told a reporter from Yangcheng Evening News that according to the conventional process, the home beauty device will be re-launched after getting the certificate, and it will be the end of the year at the earliest.

In addition, according to the research report of Cinda Securities in June last year, Huazhi, Yameng, and Miguang have completed the filing of clinical trials. However, there is still a long time before the record is obtained. "In the long run, this is good for businesses and industries, especially for consumers. The staff member made an analogy, which is like the difference between food and medicine, food does not advertise efficacy. The supervision of radio frequency beauty devices has been raised from "small household appliances" to "Class III medical devices", which objectively limits "boasting".

Lin Chun, deputy to the Guangzhou Municipal People's Congress and chairman of Guangzhou Keying Cosmetics Co., Ltd., said that the implementation of the new regulations on radio frequency beauty devices reflects the country's emphasis on the high-quality development of medical devices. High-quality products are a boost to the healthy development of the industry and the international market.