Is the Device Safe?
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.
During the comprehensive testing process, several important results can be highlighted that provide valuable insights into the safety profile of the RLRL device. Notably, for the retinal photochemical aphakic light hazard, the evaluation of E(A-R) yielded a value of 0.0797 μW/cm², which is “well below” the limit of 440 μW/cm² (Figure 2).
Additionally, regarding the unweighted anterior segment visible and infrared radiation irradiance EVIR-AS, the assessment of E(VIR-AS) indicated a value of 79.71×10-6W/cm2 which fully complies with the limit of 4w/cm2. Furthermore, the evaluation of retinal visible and infrared radiation thermal hazard EVIR-R yielded a value of 27.357 x 10-6 W/cm², which is well below the limit of 0.7 W/cm² (Figure 2).
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: firstname.lastname@example.org
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.