World's First Active Rigid Contact Lens Care and Disinfection Device by 3N Eyecare Receives NMPA Approval

May 13, 2025 12:02 CST Updated 12:02

3N Tech

Manufacturer and R&D of Corneal Contact Lens Care Technology and Products

Approved for Marketing: New Active Rigid Contact Lens Care and Disinfection Device

April 29, 2025, by3N Eyecare("3N Tech") applied for "Rigid Contact Lens Care and Disinfection Device" (hereinafter referred to as "MirrorClean GP Rigid Contact Lens Care Disinfection Device") wasOfficially Approved by the National Medical Products AdministrationLaunched in China, Registration Certificate No.: Z20253160887.

The applicable scope of this product is: used in conjunction with 0.9% sterile sodium chloride solution for the cleaning and disinfection of rigid contact lenses (fluorosilicone acrylate rigid lenses).Only need to use saline, it can provide simple, safe, and efficient disinfection and protein removal care for special lenses such as orthokeratology lenses and scleral contact lenses.Rigid Contact Lens Care Enters the Powered Era, bringing better options for contact lens wearers in China.

As an innovation-driven biotech company, 3N Eyecare has been deeply engaged in the ophthalmology sector since its establishment in 2015. Through relentless efforts and dedication, the company has already achieved...More than 150 patents in China and abroad。

As early as January 2022, the company based onThe 3N Eyecare Lens Regenerator (RigidCare, ReO2) Developed with the Brand-New Elepy® Electrophoresis-Dissociation Technology, successfully obtainedFDA Certification. This product is the world's first result of creatively applying biomolecular electrophoresis protein removal technology to the field of contact lens care.Currently being sold in overseas markets, has garnered widespread attention in the market.

Particularly, in January 2024, the 3N Eyecare rigid contact lens cleaning and disinfection device successfully passed the special review process for innovative medical devices, becoming...The First Ophthalmic Device Related to Rigid Contact Lens Care in China to be Selected for the Green ChannelNot only that, but it is also the only product and technology in the optometry field to date that has been approved to enter the Class III Innovative Medical Device Green Channel.

From the technological breakthrough of "innovative medical devices" to the practical needs of clinical applications, this product from 3N Eyecare is not only a result of technological development but also embodies significant clinical value in addressing pain points in rigid contact lens care. The following analysis delves into the key issues that have long existed in the field of rigid contact lens care, starting from the clinical background.

Technological Innovation: Elepy® Technology Reshapes the Paradigm of Rigid Lens Care

3N Eyecare has consistently focused on the aforementioned pain points of contact lens care, dedicating itself to the development of corneal contact lens care products. It aims to minimize the risk of complications such as corneal infections and dry eye caused by improper care of corneal contact lenses and has developedA New Active Rigid Contact Lens Care and Disinfection Device Developed Based on Elepy® Technology。

Technical PrincipleUp, Jingjing GP Rigid Contact Lens Care and Disinfection DeviceBy dissociating 0.9% sterile sodium chloride solution, a chlorine-containing solution is generated to eliminate microorganisms such as bacteria on the lens, achieving lens disinfection.，Electrophoresis is used to direct the movement of charged proteins in the gaps or on the surface of lens materials. Chloride-containing solutions break protein peptide bonds, enhancing the effect of electrophoretic protein removal.。

MirrorClean GP Rigid Contact Lens Care and Disinfection DeviceAs an innovative product for rigid contact lens care, it has significant technical advantages, mainly reflected inDisinfection and Protein Removal, Operation MethodTwo aspects:

More Efficient and Thorough Disinfection and Protein Removal: Utilizing the principle of electrophoresis-dissociation, hypochlorous acid is generated from saline solution for disinfection. Taking advantage of protein charge and electrophoretic mobility, the technologies of "protein electrophoresis" and "electrochemical dissociation" not only eliminate microorganisms but also cleave protein peptide bonds, reducing their molecular weight to deeply clean protein deposits in lens micropores and on the surface.

Easy to operate and improve compliance: Without the need for manual soaking and rubbing, users simply place the lenses in the device and press a button to complete standard care in 15 minutes and intensive care in 30 minutes. The simplified operation process improves compliance with lens care, which is particularly significant in ensuring the safe use of lenses for children and adolescents who wear orthokeratology lenses over the long term.

Overall, the MirrorPure GP Rigid Contact Lens Care and Disinfection Device, as an innovative product for rigid contact lens care, integrates cutting-edge care concepts and provides a brand-new solution for lens maintenance with its unique technology. It offers diverse and high-quality options for patients and users in their daily use.

Expert Evaluation

The Jingjing GP Rigid Contact Lens Care and Disinfection Device has received high praise and acclaim from numerous ophthalmology experts both in China and internationally for its excellent clinical performance.

Evaluation by Domestic Experts

Professor Fan Lü｜Eye Hospital of Wenzhou Medical University

Traditional contact lens care technologies have pain points such as insufficient cleaning efficiency and poor user compliance. The Elepy® technology, which utilizes electrophoretic dissociation, breaks down protein on the lens surface through a directional electric field, overcoming the limitations of traditional chemical cleaning. As the world's first contact lens care device that only requires 0.9% sterile sodium chloride solution for care and disinfection, it passed through the National Medical Products Administration’s green channel for innovative medical device approval in 2024. The birth of Elepy® technology represents a disruptive innovation to traditional care methods. It not only improves cleaning efficiency but also significantly reduces the risk of lens wear and complications caused by manual rubbing.

Professor Lihua Li | Tianjin Eye Hospital

This device, when used with saline solution, efficiently removes proteins and kills bacteria, significantly reducing the risk of lens-related complications. It provides a reliable solution for the daily care of orthokeratology lenses. Its convenient operation reduces the frequency of manual rubbing and enhances patient compliance, offering significant clinical promotion value.

Professor Pauline Cho | Department of Ophthalmology, West China Hospital, Sichuan University

Very pleased to see the effective germicidal and protein removal data brought by Elepy®, and its wider application in clinical settings can more effectively address issues related to contact lens care for patients. Effective germicidal and protein removal is indeed the most crucial aspect to truly solve the pain points of contact lens care. Looking forward to more clinical outcomes in the future.

Professor Longqian Liu | Department of Ophthalmology, West China Hospital, Sichuan University

Patients wearing OK lenses are mainly children and teenagers, who have relatively weak adherence to traditional care, resulting in substandard cleaning effectiveness. However, the simplified operation brought by Elepy® technology significantly improves the cleaning efficiency among teenagers, avoiding complications caused by low compliance.

Director Tianbin Lü | Department of Ophthalmology, Henan Provincial People's Hospital

Currently, the infection rate of Acanthamoeba has been increasing year by year. A significant portion of the infected population consists of contact lens wearers, including adults who use tap water to clean their lenses. The two main factors contributing to Acanthamoeba infections are exposure to the pathogen and damage to the ocular surface. In addition to educating patients, it is crucial to interrupt the transmission routes of Acanthamoeba. Elepy® has been tested to effectively kill Acanthamoeba, addressing a major challenge at the source.

Director Zhang Yang | Beijing Tongren Hospital, Capital Medical University; Microbiology Laboratory, Beijing Ophthalmology Research Institute

I would like to add some risk factors. Clinically speaking, children over 12 years old, especially those who are boarding, are more prone to this issue, particularly those wearing 2-3 or more pairs of lenses. Parents of boarding children, who are often busy with work, should pay more attention to health education and use effective technical methods to correct these habits, which is an excellent starting point. At the same time, monitor the ocular surface condition while wearing lenses and take preventive measures.

Evaluation by Overseas Experts

Professor Yue Liu | University of California, Berkeley, School of Optometry

The rigid contact lens deposits are diverse and face many challenges. The traditional contact lens care model, without the development of new material components, has already struggled to create innovative products with better effects. However, Elepy® technology takes a different approach. Paired only with saline solution, it combines the effects of electrophoresis and electrochemical dissociation, demonstrating superior protein removal and bactericidal effects. It even has potent killing effects on all pathogens and viruses (including spores). It can be said that Elepy® has truly redefined the field of contact lens care, a result that brings us great joy.

Professor Vincent Yap | KPJ Eye Centre, Malaysia

The pain points in scleral lens care lie in the difficulty of traditional cleaning methods to remove all bacteria, especially for patients with eye injuries, where the risks are higher. Additionally, the accumulation of deposits can reduce the wettability of the lenses, affecting their wear and performance. Based on clinical feedback collected from its application, after scleral lens patients used Elepy®Scleral, they experienced a significant reduction in fogging, dryness, and discomfort, extending comfortable wearing time and improving patient compliance.

Mr. Armin Duddek | Chairman of EFCLIN

In my career, I have fitted tens of thousands of contact lenses, so I can judge the cleaning effect of contact lenses with a simple touch. I have never seen any contact lens cleaning method that can achieve such an astonishing effect as Re02.

Professor Hu Jintang | Vice President of AOMA Australia

Elepy® is already in use in outpatient clinics in Australia. Based on clinical usage, its bactericidal and protein-removal effects have received positive feedback from patients, effectively improving the ocular safety risks caused by improper care while wearing contact lenses. Frequent manual rubbing can affect the fitting parameters of contact lenses and damage the lens material itself, but Elepy® technology significantly reduces the frequency of manual rubbing during lens care without causing any harm to the lens material, thereby reducing the risk of lens damage.

Professor Leon Davies | Chairman of the Board, British Optometric Association

I am extremely surprised and delighted that 3N Eyecare has brought such revolutionary technology to this year's annual conference. I can foresee that, in the near future, the ReO2 series of cleaning products will definitely become very popular among optometrists and patients. I hope 3N Eyecare will continue to bring us groundbreaking products.

High praise from domestic and international ophthalmology experts for the Jingjing GP Rigid Contact Lens Care and Disinfection Device confirms the breakthrough value of Elepy® technology in the field of contact lens care. Domestic experts focus on its innovative breakthrough from traditional care models, affirming its significant advantages in efficient protein removal, sterilization, and improving compliance among teenagers. They particularly recognize its clinical significance in cutting off Acanthamoeba transmission and reducing the risk of complications. Overseas experts, starting from the innovation in technical principles and global care challenges, highly commend its potential to redefine industry standards, as well as its excellent performance in specific scenarios such as scleral lens care and material protection. These authoritative endorsements from different clinical settings not only highlight the core advantages of safety and efficiency but also markChina's Original Technology Gains Deep Recognition in the International Optometry FieldWith the widespread application of Elepy® technology, it is expected to establish a new concept in contact lens care technology, providing global users with safer and more convenient eye health protection.

Source: Qingbai Perspective