Available Red-Light Therapy Devices Effective but Exceed American Safety Limits

Although red laser therapy is a potential intervention for myopia, its rapid clinical adoption has outpaced thorough safety validation. This quality improvement study found that EyeRising and Sky-n1201 exceeded ANSI laser and ophthalmic instrument safety classifications. Photo: Eyerising International. Click image to enlarge. Despite growing clinical interest in red light therapy for myopia control, which is currently only available outside the US, the ocular safety of these laser-based instruments has not been rigorously established or published. Researchers at the University of Houston College of Optometry assessed the optical output and safety classification of four commercially available devices using American National Standards Institute (ANSI) guidelines. Their findings suggested that these laser-based red light therapy instruments deliver irradiance levels that reach ANSI safety limits within exposure times far below the recommended 180-second treatment time.This laboratory-based study, which was published in JAMA Ophthalmology, assessed the optical output and safety classification of the Sky-n1202 (Beijing Mingren Vision Technology), the Future Vision (Human Medical Technology), as well as the EyeRising and AirDoc (Beijing Airdoc Technology). The Eyerising International device has gained regulatory approval in several countries, including the UK, Japan, Vietnam, Australia, Colombia and Ecuador, and has been reported by the company to have been used for more than 100,000 children for red laser therapy in China and in more than 250,000 sessions completed outside of China.Radiometric power was measured with an integrating sphere radiometer at 1cm and 10cm distances through a 7mm aperture and retinal irradiance calculated for 2mm to 7mm pupil diameters. Safety classification was investigated according to ANSI Z80.36-2021 and ANSI Z136.1-2022 standards.The Sky-n1201 and EyeRising devices reached ANSI Group 1 limits within exposure times of 2.8 and 1.4 seconds, respectively, for a 7mm pupil and are classified as Class 1 and 2M laser devices, respectively. The Future Vision device reached Group 1 limits under extended exposure times of 253 seconds or longer but remained within limits for Class 1 laser classification. The light-emitting diode–based AirDoc produced diffuse illumination with a time to Group 1 limit of 22,761 seconds, classifying it as Group 1.“ANSI safety guidelines provide a valuable, standardized method for evaluating such devices. Lasers and laser products are broadly classified under ANSI Z136.1 as Class 1 through Class 4, and all classes except for Class 1 pose the risk of being hazardous,” the study authors wrote in their paper. “For devices that exceed Group 1 classification and maximum permissible exposure thresholds, caution is warranted until independent studies confirm acute and long-term safety under repeated clinical use conditions. Instruments with LED light sources or diffuse illumination may provide safer profiles.”The researchers did note that their study was conducted under controlled laboratory conditions, which may not fully replicate in vivo retinal responses during clinical use. Although laboratory evaluation allows for the precise and standardized measurement of optical output and safety classification, it does not account for factors such as ocular media absorption, fixation behavior or retinal adaptation.“Red laser therapy for myopia may show efficacy, but our measurements found that laser-based devices exceed established ANSI safety limits within seconds, far shorter than the recommended treatment time,” says Lisa Ostrin, OD, PhD, coauthor of the paper. “These findings, together with emerging clinical reports of retinal injury and recent regulatory changes in China, highlight that safety validation has not kept pace with adoption. Until independent long-term safety data are available, caution is warranted, especially in children.”The study concluded that establishing a balance between therapeutic efficacy and ocular safety remains essential to ensure that this intervention intended to preserve lifelong vision does not itself pose avoidable risks that outweigh benefits. Click here for the journal source. Ostrin LA, Schill AW. Safety evaluation of four red light therapy devices for myopia. JAMA Ophthalmol. February 5, 2026. [Epub ahead of print].This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.