The IPL hair removal device generally consists of a host, a treatment head, and a filter. It is an over-the-counter device used to remove excess hair from adults and is suitable for use at home or in medical institutions. Regulated in the United States according to Medical Device Class II, product code: OHT.Figure 1 IPL hair removal device product imageThe IPL hair removal device utilizes the blackness of hair to absorb intense pulsed light (IPL), converting energy into heat, causing protein coagulation and necrosis, and promoting hair loss.In 1975, Thomas Fitzpatrick, an American dermatologist, classified the skin of people of all races into six categories, namely Type I to VI. This classification is based on the original color of the skin (non illuminated area), the color of the eyes and hair, and the skin's response to light. The IPL hair removal device is suitable for adults with Fitzpatrick I-IV skin types. Users with skin types V and VI have higher levels of melanin in their skin and are more likely to experience adverse events after use. Therefore, it is not recommended for people with skin types V and VI.Note: The Fitzpatrick classification information comes from Skin typing: Fitzpatrick grading and others, Vishal Gupta, Vinod Kumar Sharma;  Clin Dermatol. 2019 Sep-Oct; 37(5):430-436.The IPL hair removal device applied for this time has a cooling effect, and the key component for cooling is the cooling plate, which cools based on the Peltier effect. When current flows through the contact point formed by two different conductors, electrons flow from the low-energy P-type material to the high-energy N-type material. Electrons jump from the low-energy level to the high-energy level, which is manifested as electron heat absorption, forming a cold surface (the cold surface of the cooling plate), and then in the process of hair removal, contact cooling is carried out through the skin of the contact area.The common hair removal devices on the market are Ice Point and Sapphire Hair Removal Devices, both of which achieve cooling effect through cooling fins. The difference lies in the difference in the cooling fins, with the former being aluminum alloy and the latter being sapphire, and the cooling fins being the same; Secondly, sapphire can reduce energy leakage, have fast light output speed, and improve hair removal speed.The main regulations that the IPL hair removal device application process must comply with are shown in the table below:In order to effectively pass the audit and minimize the risk of issuing supplements as much as possible, we utilized our rich FDA work experience in the early stages of accepting customer commissions to take preventive measures for customer product testing, instruction manual specifications, etc. Ryan Ni submitted a complete set of application materials to the FDA on August 29, 2022, and the entire review process went smoothly. During the interactive review, he provided explanations and clarifications on several unclear areas for the reviewers, but did not raise any additional issues. Received an official approval letter from the FDA on November 17, 2022. The entire submission to approval process takes no more than 3 months. (K-number: K222598) During the process of preparing FDA 510 (K) application materials, special attention should be paid to:1) Selection and comparison instructions for substantially equivalent devices. The declared device and the compared device should have the same expected use, applicable population, applicable skin color, applicable hair color, wavelength, energy density, pulse duration, output energy, service life and other performance parameters. When the performance parameters are different, the differences should be reasonably explained to ensure that they will not cause safety and effectiveness issues. If necessary, relevant testing data should be provided for demonstration. When selecting a comparison instrument, choose one. When there are multiple comparison instruments, choose the primary one.2) Household medical devices have strict requirements for product labels and instructions, which must be complete and comply with regulatory requirements. The content should be presented in a visual way such as charts, and the grammar should conform to the local language habits in the United States. Therefore, it is recommended to have personnel familiar with the local language in the United States review the grammar of the instructions before application.

Congratulations to Ruini for obtaining FDA 510 (K) approval for the electric nasal cannula in the United States within 2 months, once again breaking the record for fast FDA 510 (K) approval in the United States!Electric nasal suction devices generally consist of a main body and suction components, and are a product used to remove nasal secretions and mucus from children. Regulate according to medical devices in the United States.Ryan Ni was commissioned by a client to handle their company's electric nose wash FDA510 (K) in April 2022. After obtaining the product input information, complete the FDA 510 (K) application materials and submit the complete set of application materials to the FDA official on August 23, 2022. The entire review process was very smooth, and during the interactive review, explanations were given for several mistakes and areas that the auditor was unclear about, but no other issues were raised. Received an official approval letter from the FDA on October 21, 2022. The entire submission to approval process takes no more than 2 months.Ruini lives up to the customer's trust! Accurately grasping product features and mastering FDA regulatory requirements are the conditions for quickly obtaining FDA 510 (K) approval. The concept of professionalism, focus, and dedication is the key to achieving certification success.

Recently, the blood glucose meter and blood glucose test paper (glucose dehydrogenase method) products of Shenzhen Aole Medical Equipment (Shenzhen) Co., Ltd. have been awarded the NMPA registration certificate for medical devices by the Guangdong Provincial Medical Products Administration with the assistance of Shenzhen Ruini, adding new members to blood glucose monitoring!Here, Ruini shares some points that need to be noted during the NMPA registration review process for blood glucose meters and blood glucose test strips:                                                                           

Background IntroductionWith the continuous improvement of the living standards of the domestic people, their pursuit of beauty is unprecedentedly high. Based on market demand, a large number of household beauty devices have emerged, such as IPL hair removal devices, phototherapy products, radiofrequency beauty devices, Therma, etc. Based on the changing demand in this market, in order to reasonably control the risks of beauty devices, the Food and Drug Administration is gradually referring to the regulatory model of the US FDA and incorporating beauty devices as medical beauty devices into the scope of medical devices for management in batches.In March 2022, the bureau officially issued a notice requiring the inclusion of radiofrequency beauty devices in medical device supervision and their entry into the market under medical device licensing from April 1, 2024. 　　In April 2022, the bureau issued a notice soliciting opinions on the "Guiding Principles for Classification and Definition of Radiofrequency Beauty Products" (draft for comments). RF beauty devices are classified as follows:                  In July 2022, the bureau officially proposed classification and definition opinions for radiofrequency beauty products:　 Medical beauty is a new opportunity and trend in the development of medical devices. Based on this, Guangdong Province has issued relevant opinions on supporting the development of the medical beauty industry - the "Letter from the Office of the Guangdong Provincial Health Commission on Soliciting Opinions on Medical Beauty Surgery Projects and Their Graded Management Catalogue in Our Province" (hereinafter referred to as the "Draft for Soliciting Opinions").With China's economic growth and consumption upgrading, the medical beauty industry in China has developed rapidly, and its market size has jumped to second place. The industry has great development space and fierce market competition. The market size of China's medical beauty market has increased from 99.3 billion yuan in 2017 to 1891 billion yuan in 2021, with a compound annual growth rate of 17.5%. The growth rate of China's medical beauty market is much higher than the total market, and it is expected that the market size of China's medical beauty market will reach 226.7 billion yuan in 2022. Section 2: Strong AllianceRui Enni Consulting has been working in the medical device consulting industry for 9 years and has rich experience in domestic and international registration of medical devices. At present, there are 20 full-time consultants with complete project service capabilities (including design review for domestic and international markets, factory specifications, registration agency, system counseling, clinical trials, production licensing, education and training, and long-term consulting services).The customer registered for the NMPA radiofrequency skin therapy device was established in 2003 and is one of the earliest high-tech enterprises in China focused on the medical beauty industry. The enterprise has numerous high-quality talents with strong capabilities in design and development, quality management, and manufacturing, providing ODM and OEM services for top domestic and foreign brands.In the context of medical beauty enterprises, the client company has decided to register Class III radiofrequency skin therapy devices based on their own development needs. After multiple rounds of negotiations and discussions with various consulting firms, the client ultimately chose Rui Enni Consulting. This registration project is an important "iconic Class III medical device registration project" for Ruienni in the field of medical beauty devices. Ruienni is determined to make this RF project a golden model for enterprise services. It marks an important milestone in the development of Ruini in 2022; It also marks Ryan's active progress towards higher, faster, and more professional directions. This project has significant strategic importance for Rainey. At the beginning of the project kickoff meeting, the client's project representative delivered a warm speech. During the process, the customer representative explained the strategic significance of this registration project from the perspective of the enterprise itself, as well as the challenges and opportunities that the enterprise will soon face.Mr. Wang, the founder of Ruini, was also invited to deliver a speech. The project was summarized from various aspects such as the difficulty of product registration, registration plan, and project service team, and received warm applause from the client.At the end of the meeting, the founder of Ruini (left in the picture below) and the general manager of the client company (right in the picture below) signed the "NMPA Registration Agency Consulting Contract for RF Skin Treatment Equipment", and the project was officially launched. Section 3: OutlookAfter the project is signed, the next step will be for all members of the Ruini project team to participate in the service process. I believe that with mutual trust, sincere cooperation, and efforts from both parties, we can obtain the Class III product registration certificate and production license within the target plan.When we receive good news in the future, we will publish another article to report it to everyone!!!  

Mechanical root canal file is a dental rotary instrument that needs to be used in conjunction with a dental mobile phone to provide power. The machine used root canal file consists of a handle and a head working end. The body of the file is made of nickel titanium alloy, and the working end has grooves or spiral cutting edges. It is used for root canal preparation, auxiliary filling (i.e. cutting, leveling, cleaning, and shaping of dental bones, root canals, etc.) in dental treatment. The machine root canal file consists of an operating part and a rod, with a working part with a cutting edge on the operating part; The operating part is made of nickel titanium alloy material.Target users: The product must be used by dentists who have received formal training in root canal treatment. The expected usage location of this product is medical institutions, dental clinics, and similar occasions.Our company was commissioned by the client to handle the first registration of NMPA Class II medical devices for their company's machine root canal files at the end of December 2021. After 7 months, Rui Enni lived up to the customer's expectations and received the registration certificate approval on July 1, 2022. (Approval date: June 29, 2022, registration certificate number: Yue Xie Zhu Zhun 20222170852)After this registration, I have a few experiences to share with you:1) [Sensitive words] Step, first classify the root canal files according to their shape. The types of mechanical root canal files are complex, and according to their shape and taper, they can be classified into standard instruments, tapered instruments, molded instruments, non tapered instruments, and non single tapered instruments. The standard requirements corresponding to different classifications are also different.2) The second step is to carefully identify the type of root canal file within the applicable standards. Even for the same standard, each standard chapter should be carefully differentiated based on the different types of root canal files.3) Overall, from a professional perspective in the field of mechanical root canal filing, there are many shortcomings in the YY0803 sequence standard applicable to root canal filing. In terms of some content, most of the products that have already been launched do not actually meet some of the requirements of the YY0803 sequence standard. From the perspective of the reviewing teacher, mandatory requirements must be met. So, how to solve these contradictory problems is currently the challenge we are facing.4) There are many models and specifications of root canal files registered this time, with 56 registered models, and dozens of specifications are subdivided for different models. The product testing and issuance of test reports are also very patient tests. When testing at the provincial institute, the institute considers the model specifications to be large and is only willing to provide test reports for three main inspection models. All other models with differences in specifications need to be provided by the manufacturer themselves. Fortunately, due to policy changes, the drug regulatory authority can recognize the self testing reports of enterprises. This greatly saves product testing time.In summary, the NMPA registration of root canal files needs to focus on the compliance of standard terms and the consistency of similar compared products.

Rongfeng breast pump has obtained FDA 510K certification approvalK212884Electric breast pumps are classified as Class II medical devices in the United States Medical devices and products need to comply with the US FDA's regulations on medicine Requirements for medical equipment.The purpose of an electric breast pump is to allow lactating women to secrete and collect milk from their breasts. It is designed for individual users.The electric breast pump forms a sealed area around the nipple by sucking on accessories, and the air inside the sealed area is pumped away by the air pump, creating a vacuum and applying suction to the breast,Then release suction to stimulate lactation and extract milk. Milk is collected in the bottle.Due to the busy workload, more and more breastfeeding women choose to participate in work during their lactation period, and the use of electric breast pumps is safe Fully hygienic and convenient,Rongfeng has chosen to entrust us to handle the registration of their company's FDA 510K certification in the United States. Rui Enni fulfilled the client's commission and completed the approval of FDA 510K certification at the beginning of 2022.After this registration, there are several experiences that need to be shared, including:1) The breast pump is suitable for lactating women, single patient use, and needs to be cleaned and disinfected before use Poison;2) The testing of vacuum negative pressure needs to be ensured during operation;3) The instructions for using the breast pump need to comply with the requirements of the US Centers for Disease Control and Prevention.