Safety Concerns Raised Over Some Repeated Low-Level Red Light Therapy Devices for Myopia Control: JAMA

A new study published in the Journal of American Medical Association showed that the safety profile of recurrent low-level red light (RLRL) treatment devices used to manage myopia varies. Two devices (Eyerising and Sky-n1201a) exceeded set safety limits for lasers and ophthalmic light exposure, according to investigators.

Red laser therapy, or repetitive low-level red light, has become a popular treatment for myopia in Asia and is being considered more and more internationally. However, there hasn't been a thorough assessment of the ocular safety of commercially marketed devices. Therefore, following American National Standards Institute (ANSI) requirements, this study was carried out to evaluate the optical output and safety categorization of four commercially available red light therapy devices for the management of myopia.

From November 25, 2023, to April 30, 2024, a laboratory-based assessment of the Sky-n1201, Future Vision, EyeRising, and AirDoc devices was conducted as part of this quality improvement project. Radiometric power was measured using an integrating sphere radiometer at 1- and 10-cm distances through a 7-mm aperture and retinal irradiance computed for 2- to 7-mm pupil diameters. Safety categorization was evaluated according to ANSI Z80.36-2021 and ANSI Z136.1-2022 standards. The period of data analysis was November 25, 2023, through September 10, 2024. The key conclusion was analyzing the time to the group 1 safety limit and the ANSI device classification. This was assessed by laboratory-based examination of 4 devices and evaluating radiometric power at various pupil diameters.

The Sky-n1201 and EyeRising devices met ANSI group 1 restrictions within exposure durations of 2.8 and 1.4 seconds, respectively, for a 7-mm pupil and are categorized as Class 1 and 2M laser devices, respectively. The Future Vision gadget surpassed group 1 limitations with lengthy exposure durations of 253 seconds or more but stayed inside restrictions for Class 1 laser categorization. With a time to group 1 limit of 22,761 seconds, the light-emitting diode-based AirDoc provided diffuse lighting and was categorized as group 1.

Overall, these results imply that during exposure intervals less than the suggested 180-second treatment duration, laser-based red light therapy devices provide irradiance levels that meet ANSI safety requirements. These results, together with new clinical reports of retinal injury and China's recent regulatory categorization of red laser devices as Class III, underscore the necessity of thorough, independent safety validation prior to broad pediatric usage.

Reference:

Ostrin, L. A., & Schill, A. W. (2026). Safety evaluation of 4 red light therapy devices for myopia. JAMA Ophthalmology, 144(3), 255–258. https://doi.org/10.1001/jamaophthalmol.2025.5660