Reporters Zhang Yue and Cao Xueping reported in Beijing
As a medical beauty project for tightening the skin, Thermage is favored by many consumers for its more obvious effect. Thermage is a transliteration of "Thermage" and has become synonymous with medical beauty devices such as radiofrequency therapists.
In recent years, the chaos of medical beauty has been repeatedly prohibited, and the Thermage project is the hardest hit area of "black medical beauty". In November 2020, the China Plastic Surgery and Beauty Association released a medical beauty network public opinion and risk warning briefing, showing that during the reporting period, the spread and attention of the Thermage project was relatively high, mainly focusing on the relevant events such as thermage counterfeit equipment, parallel goods probes, adverse reactions, disfigurement and so on.
According to the official website of the State Food and Drug Administration, the product radiofrequency therapy instrument Thermage CPT System (commonly known as "Thermage IV" in medical beauty) is used for non-invasive treatment of wrinkles around the body, face and eyes, and belongs to the third class of medical devices. At the end of 2020, the name of the product agent was changed from Bolun (Shanghai) Trading Co., Ltd. to Sota (Shanghai) Health Management Co., Ltd. (hereinafter referred to as "Sota Shanghai").
The State Food and Drug Administration recently issued an announcement to adjust the content of the "Classification Catalogue of Medical Devices" for 27 types of medical devices. Among them, the name of the product, such as radio frequency therapy instrument, radio frequency skin treatment instrument and other radio frequency treatment (non-ablation) equipment, in accordance with the class III medical device management.
Regarding the market application of the Thermage project, the reporter of China Business Daily interviewed Liu Ying, attending physician of the Laser Beauty Department of the Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine. Liu Ying said that when consumers consider medical aesthetic projects, effectiveness should be the first factor; the second is safety, including instrument safety, institutional safety, and doctor safety (doctors are professional and credible); the third considers cost performance, and then other dimensions such as environment and service.
Chaos is frequent
In 2002, Solta Medical Corporation ("Sota Medical") developed and launched the first Thermage product, the first RF device approved by the FDA to tighten skin and treat wrinkles.
Liu Ying introduced that Thermage belongs to the medical beauty project of radio frequency energy source, rf is a high-frequency electromagnetic wave, which produces positive and negative ion shock after entering human tissue, which brings about 6 million frictions a minute, generates powerful thermal energy, interrupts loose collagen and starts remodeling. Thermage has certain advantages, first of all, there is no trauma and does not cause a "downtime" for patients; second, safety is internationally recognized while ensuring results; and finally, the treatment time is short and the maintenance time is long.
Liu Ying said that patients with mild to moderate skin laxity are suitable for skin tightening through radio frequency instruments. For patients, treatment is possible without medical contraindications, but not all are suitable for Thermage. Thermage belongs to the high-energy photoelectric, younger, tighter skin women can choose other items anti-aging, such as strong pulsed light, low-energy radiofrequency and laser, thermage is more suitable for 30 to 50 years old patients with loose skin.
In 2021, the "Q&A on Medical Aesthetic Related Products" released by the Medical Device Technology Evaluation Center of the State Drug Administration showed that the approved use of radiofrequency beauty equipment only includes skin wrinkles and atrophic scars.
On the consumer side, out of the demand for skin tightening, many consumers have frequently stepped into the "deep pit" of Thermage. In Sina's consumer complaint platform "Black Cat Complaints", the search was based on the keyword of Thermage, and consumer complaints involved medical and aesthetic institutions in many places, including the need to add money to scan the code for inspection of the equipment of Thermage, and the suspected use of fake Themaji equipment by the institution.
A consumer in the black cat complaint platform said that it checked the doctor, hospital and treatment head at a certain institution, but there was no officially certified QR code in the instrument, and then he contacted the equipment supplier to provide the instrument information, and was told that "not our instrument" and "not to distinguish whether the instrument and the treatment head can be connected as a standard for distinguishing the true from false".
The reporter learned that the agency has a number of stores in Beijing, but the name of a store in Chaoyang District can only be queried in the WeChat public account of Thermage. The reporter consulted the staff of the non-Thermage certified stores of the chain institution online, and the doctor certification provided by the Thermage official website came from the Thermage certified stores, not the stores consulted by the reporter. Customer service staff said that the agency has a total of four stores in Beijing, all of which are personally treated by the anti-aging director. In addition, "authorized authentication can be found on the official website, the probe supports scanning code verification, the probe after treatment supports taking away to ensure authenticity, and the quadruple certification all support scanning code."
Select Formal Certification
At present, Themaji WeChat public account and official website provide "four-dimensional authenticity", from the head of genuine beauty, genuine equipment, professional institutions and professionals to provide consumers with inspection methods.
For measures such as the verification of the truth provided by Thermage official for consumers, Liu Ying believes that it is a "helpless move" of manufacturers. Liu Ying said that the original intention of the manufacturer to produce instruments is to bring better experience and effect to consumers, but due to the hot market, a series of fake instruments and fake treatment heads have appeared, and fake instruments will bring side effects to patients, including scald scars on the skin, damage to barriers, etc. Therefore, manufacturers can only try their best to recommend genuine instruments, institutions, and formally trained doctors to consumers.
According to the content of the Zhihu account registered as "Thermage Official", in 2005, 14 foreign dermatology and plastic surgery experts and professors formulated the "Thermage Standardized Operation Guidelines" through a large number of clinical data research based on years of thetherage practical experience and discussion. In 2018, the domestic Thermage Consensus Expert Group was established and jointly formulated the "Thermage Standardized Operation Guide • China Edition".
The article shows that since 2018, Thermage standardized operation training has been successfully held for four sessions.
Liu Ying introduced that the "Thermage Standardized Operation Guide • China Edition" includes expert consensus, preoperative selection indications, operation points and other content, for professional doctors, will focus more on the latest international literature and the application of instruments in the world, including parameters, playing methods, etc. Thermage Doctor's exam includes both a written assessment and an operational assessment. The doctor's reporting unit must have a genuine instrument, the doctor holds a doctor's license, and obtains the examination qualification after network training, self-training, and manufacturer training. Liu Ying said, "The therefore, the certification of Themaji actually opened up the road to Chinese doctor certification of optoelectronic equipment. ”
The Thermage FLX (commonly known as the "Thermage Five Generations" in medical aesthetics), which has not yet obtained the FDA Class III medical device certification, is also quite popular and the price is relatively higher. Liu Ying introduced that the fifth generation of thermage instrument has added cold spray technology, which can effectively alleviate the pain of patients, and the treatment head will also improve the patient experience while shortening the treatment time. In practical applications, patients choose relatively more Thermage ivy instruments, and institutions do not need to face policy pressure when using fourth-generation instruments, and the price of four generations is relatively low.
The staff of the aforementioned medical beauty institution said that the price of the fourth generation of the Thermage facial project is 12800 yuan, and the fifth generation is 23800 yuan. For the verification of the instrument, it said, "Now thermaki is officially authorized and certified, four generations can be found, and five generations cannot be found in China." ”
For consumers, fake instruments are invincible, "even the two-dimensional code of the instrument can be counterfeited." Therefore, Liu Ying also provides the following suggestions for consumers: First, consumers need to pay attention to the low project price, carefully consider the market and operating capabilities of the institution, and identify whether there is a low-price marketing trap. Second, choose projects that match spending power, do not blindly follow the trend, and follow the advice of professional doctors. In addition, Liu Ying said that patients should learn to protect themselves in the process of diagnosis and treatment, and the "beauty" of medical beauty is relatively subjective and has no objective evaluation standards, so if there is a problem, it is difficult to get satisfactory results for patients to protect their rights through professional appraisal. Patients can keep some records of the medical process to facilitate the protection of rights. "The easiest way is to choose a regular hospital institution, a formal equipment, a regular professional doctor."
The market continues to be hot
Thermage series of products has generated considerable revenue for Sota Medical, and in February this year, Sota Medical has filed a prospectus with the US Securities and Exchange Commission to apply for listing on the NASDAQ, stock code "SLTA". According to the Sota Medical prospectus, in 2020, Thermage's operating income was 250 million US dollars, of which Thermage products contributed as much as 84% to Sota Medical's revenue, while from January to September 2021, Thermage products accounted for 78% of the operating income, reaching 170 million US dollars. The Asia-Pacific region is the main contributor to Sota Medical's revenue, with revenue contributing 67% and 68% from January to September 2021 and 2020, respectively.
In the domestic medical aesthetic market, the demand for tightening anti-aging projects continues to grow. According to the "2021 Medical Aesthetic Industry White Paper" of The new oxygen, tightening anti-aging accounts for 14.5% of the entire market, which is the largest medical aesthetic project in China in 2021. According to the "2020 Medical Aesthetic Industry White Paper" of New Oxygen, Thermage is the favorite of consumers in anti-aging tightening projects.
Therefore, in the domestic medical aesthetic market, Thermage manufacturers are particularly important for promoting the standardized service of medical aesthetics. On issues such as the manufacturer's measures to promote the standardization of Thermage, the reporter called the official hotline of Sota Shanghai, and the staff said that the hotline was only a consumer product consultation telephone.
Thermage's official WeChat "Thermage Beauty" has also repeatedly pushed the way to check authentic products to consumers. Including identification of counterfeit products certification WeChat platform, head-end identification of science and other related content. At the end of March, Thermage brand store officially entered the new oxygen and Meituan.
According to the announcement of the State Food and Drug Administration, for the radiofrequency treatment instrument and radio frequency skin treatment instrument products in the 09-07-02 radio frequency treatment (non-ablation) equipment involved in the adjustment, they can apply for registration in accordance with the provisions of the Administrative Measures for the Registration and Filing of Medical Devices (Order No. 47 of the State Administration for Market Regulation). Since April 1, 2024, radiofrequency therapy instruments and RF skin treatment instrument products shall not be produced, imported and sold without obtaining a medical device registration certificate in accordance with the law.
According to the Sota Medical prospectus, on January 29, 2022, the company submitted three medical device applications to the State Food and Drug Administration, namely Thermage FLX, TR2-Return Pad and TR4-Return Pad.
For the authenticity of the instrument, sota Shanghai official hotline staff said that the Thermage certification body can be queried on the official website, at the same time, no matter what type of equipment can be queried, the official does not have several generations of sayings, only the difference in models, you can choose the model according to your own needs. "The equipment that can be certified can be scanned and queried, and there are anti-counterfeiters."