Laser-based red light devices for myopia pose safety risks

Laser-based red light therapy instruments used as an intervention for myopia have been found to deliver irradiance levels that exceed the American National Standards Institute (ANSI) safety limits within exposure times below the recommended 180-s treatment time, as reported in a quality improvement study.

Researchers performed a laboratory-based evaluation of the Sky-n1201, Future Vision, EyeRising, and AirDoc instruments. The main outcome was the time to the group 1 safety limit and the ANSI device classification. 

For each device, radiometric power was assessed using an integrating sphere radiometer at 1- and 10-cm distances through a 7-mm aperture. Retinal irradiance was measured for 2- to 7-mm pupil diameters. Safety classification was evaluated against the ANSI Z80.36-2021 and ANSI Z136.1-2022 standards.

ANSI group 1 limits were reached with the Sky-n1201 and EyeRising devices within exposure times of 2.8 and 1.4 s, respectively, for a 7-mm pupil. Sky-n1201 was classified as Class 1, while EyeRising was classified as Class 2M laser device.

On the other hand, the Future Vision device reached group 1 limits under extended exposure times of 253 s or longer, although it remained within limits for Class 1 laser classification. The light-emitting diode–based AirDoc emitted diffuse illumination with a time to group 1 limit of 22,761 s, classifying it as group 1.

These findings, along with emerging clinical reports of retinal damage and recent regulatory reclassification of red laser devices as Class III in China, raise the alarm about the safety of red light therapy devices and underscore the importance of rigorous, independent safety validation before widespread paediatric use. [JAMA Ophthalmol 2023;141:693-695; JAMA Ophthalmol 2025;143:480-488; JAMA Ophthalmol 2025;143:876-877; JAMA Ophthalmol 2025;143:197-198]