1. Device Classification
The Eyerising Myopia Management Device has been classified as a Group 1 instrument by the American National Standard for the Safe Use of Lasers (ANSI) Z80.36-2021 testing standards. This is the appropriate standard for ophthalmic instrument testing as per FDA requirements. Our Group 1 classification confirms that no potential light hazard exists when using our device. Our company, Eyerising International, is also ISO 13485:2016 certified by notified body BSI.
2. Clinical Evidence
Our device has undergone extensive clinical study, with 10 clinical trials and 4 real-world studies published in China. This brings us to a cumulative sample size of 1785 patients across our published work who have been using our RLRL therapy for a total of 9.25 years. We also have 4 ongoing clinical trials and real-world studies outside of China to confirm our multi-ethnic efficacy, with promising interim results from our Australian trial speaking to the continued efficacy and safety of our device. Importantly, in all our published studies thus far across a variety of institutions, zero significant adverse events have been reported.
3. Long-term Device Use
The device has been in the market for over 8 years and is the originator and patent holder of RLRL therapy for myopia management. This comprises 4 years of off-label and 4 years of on-label use, thereby providing ample data on its safety over several years of real-world usage.
4. Post-market Surveillance
We also have global monitoring in place for our current users, in order to continually confirm our device’s safety. To date, we have over 160,000+ patients that have used the device with 80,000+ current users. In this time, there have been 5 significant adverse events reported during our post-market surveillance. Adverse events are difficult to avoid when launching novel medical devices, and our limited number of adverse events reported within our wealth of real-world experience speaks to the overall safety of our intervention, as well as our commitment to fully updating our risk profile and instructions for use accordingly. OF note, all patients fully recovered with no permanently sustained injuries.
5. Regulatory Clearances
The Eyerising Myopia Management Device holds 7 Class II regulatory clearances in different international markets. This includes CFDA approval in China (Class II), MHRA approval in the United Kingdom (Class IIa), TGA approval in Australia (Class IIa), CE certification in Europe (Class IIa), MedSafe approval in New Zealand (Class IIa), MDA approval in Malaysia (Class B) and TMMDA approval in Turkey (Class IIa). Each of these clearances was granted following extensive risk-benefit analyses by the competent regulatory bodies, where it was deemed our extensive clinical and real-world evidence successfully demonstrated that the benefits of RLRL therapy outweigh the risks. We are also working on launching in several new international markets in due course.
- We are certified by the appropriate laser safety standards to carry no potential light hazard (ANSI Z80.36)
- We have undergone and are continuing to undergo extensive clinical studies, with no significant adverse events reported in our published work
- Through our 8 years and 160,000+ patients to date, only 5 significant adverse events have been reported and all patients made a full recovery
- We hold 7 regulatory clearances in international markets, each having been granted after extensive risk-benefit analyses determining our product’s clinical benefits to outweigh any risks
Eyerising Myopia Management Device is a classified an ANSI Group 1 Instrument
Rigorous product testing and safety assessment has been undertaken on our device. The testing process was conducted in accordance with the ANSI Z80.36-2021 standard, ensuring that our device meets the latest safety requirements and guidelines. The testing report was issued on 08 January 2023 and provides assurance of our commitment to delivering a safe and effective solution for managing myopia.
The ANSI Z80.36-2021 standard was developed by the American National Standards Institute (ANSI) that specifically addresses the safety requirements for ophthalmic instruments that that direct optical radiation into or at the eye. The standard focuses on the potential light hazard of these instruments when used in the field of optometry and ophthalmology. For the purpose of this standard, ophthalmic instruments are categorized into two groups to differentiate instruments that may pose potential hazards from those that do not.
Our device was tested by Laser Product Safety, LLC (who is authorised by the FDA ASCA-accredited testing lab, CertifiGroup in accordance to ANSI Ophthalmic – Light Hazard Protection For Ophthalmic Instruments standard). The device has successfully achieved a Group 1 instrument classification (Figure 1), indicating no potential light hazard exists.
At Eyerising International Pty Ltd, we are dedicated to revolutionizing eye care through our cutting-edge ophthalmic RLRL myopia therapy. Our commitment to safety, efficacy, and patient well-being drives us to develop exceptional products that consistently meet and surpass the highest industry standards.
To request the full report, please contact on us: email@example.com
International Approvals & Regulatory Status
The device meets the quality, safety, and efficacy standards required by medical regulators in over 30 countries across Europe and Australasia, with many more coming soon.
- Eyerising International is ISO 13485:2016 certified by notified body BSI.
- CFDA approved as Class II medical device
- CE mark as Class IIa medical device
- MHRA approved Class IIa in UK
- MedSafe Class IIa in New Zealand
- TMMDA approved Class IIa in Turkey
- Australian Register of Therapeutic Goods (ARTG) in Australia
- Medical Device Authority (MDA) in Malaysia