Safety Information
Independently tested and verified for safe, repeated use.
Independent Safety Testing
The Eyerising Myopia Management Device has been independently assessed in accordance with IEC 60825-1:2014 laser safety standards, performed by Seibersdorf Labor GmbH, an accredited laser safety testing house in Austria.
Testing used a 7 mm aperture to simulate the pupil as required by the standard (worst-case scenario) and classified emissions from Class 1 (safe in all cases) to Class 3R (low risk). The Eyerising Myopia Management Device was found to have emissions within the Class 1 safety limit for both visible (red) and infrared wavelengths.
During testing, a single measurement slightly exceeded the Class 1 limit and was therefore conservatively assigned a Class 3R designation, indicating low-risk exposure when used in accordance with the Instructions for Use.
A follow-up expert report by Dr. Karl Schulmeister of Seibersdorf Labor GmbH reviewed the full IEC 60825-1:2014 results and confirmed that the device operates within internationally accepted limits for repeated, supervised use in myopia management applications. The report further noted that measured emissions were significantly below thresholds associated with retinal injury or photothermal damage under the tested conditions.
At Eyerising International, the safety of your child undergoing our RLRL treatment is a priority. The Myopia Management Device has been thoroughly tested by independent laser safety laboratories in Europe to make sure it meets the highest international standards for home use.
During testing, experts examined how the device's red-light interacts with the eye to confirm that the light levels stay well within safe limits. Using specialised equipment that mimics the human pupil, the assessments measured exposure under a range of real-world conditions to ensure there was no risk of eye damage.
The device was confirmed to operate within strict safety thresholds set by international standards for light-based medical products. A senior laser safety specialist also reviewed and verified the results, confirming that the device is suitable for supervised use in children when operated as instructed.
This testing means that families can have confidence knowing our device has undergone extensive evaluation for quality, reliability, and safety before being approved for use in managing childhood myopia.
Class 1 Rating
Classified as a Class 1 laser product for both visible and infrared wavelengths under IEC 60825-1:2014—the safest classification.
Expert Review
Independent expert review has confirmed the device is safe for repeated supervised use in children.
Post-Market Surveillance
Ongoing surveillance across tens of thousands of patients worldwide. Any adverse events reported have resolved upon discontinuation.
Established Track Record
The Eyerising Myopia Management Device and RLRL therapy have been the subject of multiple published clinical and real-world studies conducted internationally. These studies have explored the safety and efficacy of RLRL therapy as an intervention for managing childhood myopia, involving diverse paediatric populations and research settings across different ethnicities.
The device has been used internationally for more than 8 years, with over 4 years of post-market use under regulatory approval. Published clinical trials and real-world usage data continue to contribute to understanding our device's safety profile and clinical performance.
Eyerising International has established a global post-market surveillance program. The device has been used by tens of thousands of patients worldwide. To date, a small number of significant adverse events have been reported, all of which resolved after discontinuation of therapy.
The Eyerising Myopia Management Device has been used safely by families around the world for more than eight years. Developed by experts in children's vision, it is the original and patented technology behind RLRL therapy for managing myopia.
Over this time, our device has been used both in clinical studies and in real-world settings, giving researchers and eye-care professionals extensive data about its performance and safety. This long history of use provides families with confidence that the technology is well established and carefully monitored.
Safe Usage Protocol
3 Minutes Per Session
Each treatment session is precisely 3 minutes. The device automatically stops at the end of each session.
Twice Daily
Two sessions per day, with a minimum of 4 hours between sessions.
5 Days Per Week
Treatment is prescribed for 5 days per week, allowing two rest days.
Clinical Supervision
All treatment is prescribed and monitored by a qualified eye-care professional.
Home-Based Convenience
Treatment is performed at home under the guidance of the prescribing clinician.
Non-Contact Treatment
The device does not contact the eye or eyelid during treatment.
Questions About Safety?
For more information about our laser safety testing and certifications, please contact info@eyerisinginternational.com