Blue Whale 315| Ultrasound cannon has become a worst-hit area with complaints about medical beauty: limited effect and high risk, changes in indications have triggered a “banned” storm

Blue Whale News, March 6 (Reporter Tu Jun)After she was over 35 years old, Xiao A (pseudonym) developed anti-aging pressure, and she increasingly felt that the flesh on her face couldn’t hold it and droop. As she heard more and more claims that ultrasonic cannons could resist aging, she also rushed to a fashion and went to a beauty salon to do a project. After spending nearly 10,000 yuan, her face that had just finished the ultrasonic cannons became swollen into a mahjong tile (square). She told Blue Whale Finance that her face had been swollen for about half a month. During this half a month, water would leak out of her mouth, and she felt that she would not bite tightly when she ate. At that time, she was worried about whether it hit the nerves, but later it slowly recovered. However, after the swelling, the effect was not as good as expected and she couldn’t feel the difference from the original. rdquo;

There have also been multiple complaints about ultrasonic guns on the complaint platform.

Some industry insiders pointed out that the big selling point of the ultrasonic gun is able to seize the c-terminal market and become a leader in the domestic optoelectronic pull industry is that it has passed the review of the State Drug Administration (NMPA), but it is precisely because of this, the change of its indications in the rehabilitation department, dermatology department, and plastic surgery department of medical institutions once triggered a ban. In addition, some doctors also said that if used improperly, it may cause irreversible skin damage, and both doctors and patients should pay attention to the risks.

“The principle of barbecue? Medical beauty behavior has two sides, and risks need to be warned.

On the Black Cat complaint platform, there are 274 complaints that contain the search term ultrasonic cannon.

“There was no effect at all. Compared with the photos before and after surgery, there was no effect. The facial swelling lasted for about 15 days, and the swelling was completely reduced in about 20 days. After the swelling subsided, it did not achieve the effect of tightening and lifting. It was a serious false publicity, and deceived consumption, and after-sales service has been perfunctory saying that the time is not up yet. So far, more than a month has passed and there is still no effect. rdquo; Some consumers have filed complaints on the Black Cat Complaint Platform.

In addition to facial swelling after surgery and consumers feeling that there is no effect, some consumers also reported that there is a cabbage price routine in the industry, that is, products such as 998 and 1888 that are far lower than the market price are used to attract customer flow, but they cannot be verified at the scene; In addition, there are also doctors who spend less time or increase their energy, making beauty seekers swell into pig heads on the scene.

Blue Whale Finance found that on platforms such as Xiaohongshu and Douyin, some doctors and beauty practitioners will use some videos about popular medical beauty to guide people. When consumers ask questions or pay attention, their little assistants will appear and make appointments. Items, etc.

When Lanjing Finance consulted a junior assistant to a plastic surgeon in a tertiary A hospital whether the ultrasonic cannon project was safe, it said that the ultrasonic cannon was non-invasive and very safe. rdquo; But when asked if it had relevant qualifications and was approved for use by the National Drug Administration, he said that it was not clear and could check it himself.

Regarding the principle of ultrasonic cannon, an official micro-blog of a third-class hospital showed that ultrasonic cannon is a kind of focused ultrasound that can form higher intensity and energy. It uses focusing technology to focus low-energy ultrasound from outside the body to a specific area in the body to form a high-energy target, which vibrates the molecules in the area, generates strong shear force, and generates heat through friction to increase the temperature of the tissue, causing thermal damage to the tissue. Without causing damage to other surrounding tissues. Its heat energy can reach a high temperature of 55-70 degrees in the subcutaneous fascia layer, and the fascia tissue is heated and has a tightening effect; local fat tissue can undergo coagulated necrosis, which can play a role in dissolving lipids. Compared with existing laser, radio frequency wrinkle removal and other methods, focused ultrasound can act more deeply on the facial SMAS layer, non-invasively enhance sagging skin on the face and neck, and improve wrinkles.

However, the article does not indicate the risks and side effects of ultrasonic cannons.

Dr. Mahida, who is briefly referred to as the deputy chief physician of the Department of Cosmetic and Plastic Surgery of the First Affiliated Hospital of Dalian Medical University, pointed out on a video platform that medical beauty is actually a medical behavior with two sides. While achieving good treatment effects, there may also be some risks associated with complications. The principle of ultrasound instruments is to focus hot energy on a certain point on the subcutaneous fascia layer, thereby forming a scarring tightening. What people usually say about the principle of barbecue is actually correct for students who like to listen to the vernacular. However, if we use barbecued meat as a metaphor, the human body may be able to recover by 3 minutes of cooking without causing particularly serious sequelae. However, if it is cooked by 7 minutes of cooking, irreversible damage will easily form, and the subcutaneous soft tissue will form scarred degeneration. Many people think that the more hair they have, the better, and that facial proteins will denature. The consequence is what people often call separation of flesh and skin and premature overdraw of youth.

Some doctors also told Blue Whale Finance that some doctors have doubts about the function and damage of ultrasonic cannons. Whether the damage is what we want, including everyone’s energy strength and body adaptation, which requires a very experienced doctor.

Changes in indications and a banned storm has been triggered

At the end of last year, the State Food and Drug Administration (NMPA) made important adjustments to the registration certificates of ultrasound therapy equipment of seven companies in Hunan Province, and uniformly cancelled the labeling of these equipment originally suitable for the auxiliary treatment of diseases related to rehabilitation, dermatology, plastic surgery, and obstetrics and gynecology in medical institutions. This attracted the attention of many beauty seekers, and everyone once thought that ultrasound cannons were banned.

However, on March 5, Blue Whale Finance conducted a search on the official website of the State Food and Drug Administration with an ultrasound treatment instrument and found that six registration certificates of the Hunan Province Drug Administration seemed to have changed again.

Blue Whale Finance conducted a search on the official website of the State Food and Drug Administration using ultrasound therapy equipment, and showed that a total of 80 registration certificates were approved, all of which were approved for Class II devices, the so-called Class II device approval.

The approved indications for most of these products are suitable for adjuvant treatment of scapulohumeral periarthritis, cervical spondylosis and soft tissue pain. Blue Whale Finance looked through these 80 registration certificates and found that some of the approved indications of products of 5 companies are still used in the rehabilitation department, dermatology department, and plastic surgery department of medical institutions. They are Hunan Peninsula Medical Technology Co., Ltd., Simis Medical Technology (Hunan) Co., Ltd., Hunan Xingrui Medical Technology Co., Ltd., Hunan Hande Minimally Invasive Medical Technology Co., Ltd., and Changsha Polida Medical Technology Co., Ltd.; In addition, some products of Hunan Jianfeng Laser Medical Technology Co., Ltd. have been approved for use in the rehabilitation department and dermatology department of medical institutions. The approval authority for the above six registration certificates is the Hunan Province Drug Administration.

Compared with previous media screenshots, the indications for the above-mentioned approved registration certificate seem to have changed.

However, taking Hunan Peninsula Medical Technology Co., Ltd., the most famous ultrasonic cannon, as an example, although it has increased the use of rehabilitation departments, dermatology departments, plastic surgery and cosmetology departments and other departments in medical institutions, it is stated that it is auxiliary treatment.

In addition, some models and specifications of products from two companies, namely Zhengzhou Pinzheng Future Medical Technology Co., Ltd. and Guizhou Polida Medical Device Co., Ltd., have been approved to use ultrasonic energy to help facial skin tighten and eliminate wrinkles without tissue degeneration. rdquo; The approval authorities are Henan Province Drug Administration and Guizhou Province Drug Administration respectively.

“Auxiliary treatment is always a marginal goal. Once merchants promote its efficacy in medical beauty organizations, a slight carelessness will lead to consumer rights protection and disputes. rdquo; Tian Yahua, vice president of the Medical Beauty Institution Branch of China Plastic and Cosmetic Association, said in an interview with Blue Whale Financial reporter.

In October 2022, the State Administration for Market Regulation’s “Guidelines for the Control of False Publicity and Price Violations in the Medical Beauty Industry” and the “Guiding Opinions on Further Strengthening Supervision of the Medical Beauty Industry” issued by 11 departments including the State Administration for Market Regulation in May 2023 have further standardized false publicity.

Tian Yahua pointed out that many consumers may not know that once a medical institution is caught with medical care and deception, it may gain support in judicial practice for one refund and three compensation. When the institution knows that if it does not refund and compensation, once it is reported, the starting point for penalties for false publicity under the Anti-Unfair Competition Law is more than 200,000 yuan, and many institutions can only sacrifice their wealth to avoid disasters.

In the medical device industry, there are Class I, Class II and Class III medical device licenses. A type of medical device license corresponds to a type of medical device with the lowest risk level, such as medical cotton swabs, band-aids, etc., and its safety and effectiveness can be ensured through routine management. Class II medical devices have moderate risks and require certain measures to control their safety and effectiveness, such as thermometers, sphygmomanometers, etc. The three related types of medical devices have the highest risks and are usually implanted into the human body or used to support life, such as cardiac pacemakers, artificial joints, etc., and their safety and effectiveness are extremely strictly controlled.

It is worth noting that the State Food and Drug Administration has previously issued the “Guiding Principles for Classification and Definition of Ultrasound Devices for Cosmetic Purposes”, which describes the management of the second and third categories of medical devices respectively. Among them, as the third category of medical device management (including but not limited to), it is pointed out that the thermal effects, mechanical effects and ultrasonic cavitation of high-frequency ultrasound are used to denature human tissues, such as stimulating the regeneration and proliferation of collagen, thereby achieving the treatment of acne, fading spots, fading scar traces, Ultrasound cosmetic devices for the purpose of repairing scars, improving skin elasticity and reducing wrinkles are managed as Class III medical devices.

As for the management of Class II medical devices (including but not limited to), it is pointed out that ultrasonic beauty devices that use the energy of ultrasonic waves to achieve cosmetic purposes by promoting local blood circulation and accelerating skin metabolism without tissue degeneration are in accordance with the management of Class II medical devices. Ultrasound cosmetic devices that use ultrasound to penetrate drugs and medical devices into the human body through the skin or mucous membrane are managed as Class II medical devices (ultrasound introducers).

“Tissue degeneration is the core mechanism of anti-aging in ultrasound equipment. It stimulates collagen regeneration through precise thermal damage, and the effect is significant and reversible. However, its safety and effectiveness are highly dependent on the authenticity of the equipment, physician’s skills and postoperative management. Should be managed in accordance with Class III medical devices.& rdquo; Tian Yahua said.

Some industry insiders pointed out that overall, the overall medical and beauty industry, including ultrasonic cannons, feels confusing, and the cost for consumers to distinguish between authenticity, effects and risks is high.

Regarding how the medical beauty industry can truly achieve compliance, Tian Yahua pointed out that in the future, with the implementation of standards such as the “Regulations for the Management and Service of Beauty and Medical Institutions” and the digitalization of regulatory technologies (such as equipment scanning code verification, online self-inspection tools), etc.), the industry may gradually realize that good money drives out bad money and provide consumers with safer and transparent anti-aging services.