Safety Information
Independently evaluated and monitored for safe, repeated use.
Laser Safety
The Eyerising Myopia Management Device (EMMD) underwent testing in accordance with IEC 60825:1-2014, the internationally recognised laser product safety standard required for CE marking.
An independent expert evaluation by Dr Karl Schulmeister of Seibersdorf Labor GmbH reviewed the IEC 60825:1-2014 together with the treatment protocol of the EMMD to assess its safety profile in the context of repeated retinal exposure. Unlike high-power ophthalmic lasers used for tissue disruption or photocoagulation, the EMMD employs low-level red light delivered under a controlled treatment protocol. The review concluded that, based on established retinal injury thresholds, published human exposure data, and the expected physiological constriction of the pupil during use, there is a negligible risk of retinal injury when the device is used as intended.
A further independent review by Professor John Marshall, Emeritus Professor of Ophthalmology at University College London and Dr Karl Schulmeister concluded that the EMMD operates well below established retinal injury thresholds and presents a negligible risk of retinal damage when used as intended.1 Their assessment highlighted the device's low-power output, diffuse beam design, controlled treatment protocol, and multiple engineering safeguards as key factors supporting its safety profile.
1 Preprint manuscript available via https://www.medrxiv.org/content/10.64898/2026.05.05.26352503v1 doi: 10.64898/2026.05.05.26352503. [Peer review ongoing].
Clinical Evidence
The EMMD has been evaluated in an extensive body of clinical research, including randomised controlled trials and real-world investigations conducted across China, Australia2 and Spain3. Published studies have reported outcomes extending up to five years of follow-up, with additional clinical trials and real-world studies ongoing in several regions including Japan and the European Union.
Importantly, across published clinical studies involving thousands of participants, no serious or vision-threatening adverse events related to the device have been reported. Advanced retinal imaging studies and long-term clinical follow-up have further supported the favourable safety profile of the technology when used according to the recommended treatment protocol.
2 Bulloch, Gabriella et al. “Efficacy of repeated red-light laser therapy for myopia control in Australian children: a pilot randomised controlled trial.” Clinical & experimental optometry, 1-11. 8 Apr. 2026, doi:10.1080/08164622.2026.2648328
3 Fernández Fidalgo, María José et al. “Repeated low-level red-light therapy combined with orthokeratology for myopia control in Spain: a randomised controlled study.” The British journal of ophthalmology vol. 110,7 771-777. 22 Jun. 2026, doi:10.1136/bjo-2025-328347
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