The Formosa Biomedical Light Therapy Glasses feature a wearable design and OLED technology, focusing on effective light wavelengths to provide uniform surface light and reduce visual fatigue. They achieve the same energy-saving effects as competing products with lower power consumption.
It has been determined by the TFDA that this product is not regulated as a medical device.
In terms of product efficacy, at least one year of real-world data has been accumulated. The results indicate an overall improvement trend in users’ “attention,” “insomnia severity,” and “daytime sleepiness,” with statistical analyses showing significant differences. Overall observations show that most users reported positive feedback in sleep quality and daytime alertness. Both insomnia- and sleepiness-related measures demonstrated a decreasing trend when comparing the baseline period with the intervention periods (light exposure phase and maintenance phase), indicating consistent performance in symptom improvement. Regarding safety and usability, the product has passed the IEC/EN 62471 photobiological safety standard testing and also complies with EN 55014-1 and EN 55014-2 electromagnetic compatibility requirements. These results confirm that the photobiological risk to the eyes during use remains at a low level, while maintaining comfort and stable usability.
In terms of product manufacturing, the production facility has established a comprehensive quality management system and strictly implements it, having obtained certification for the Quality Management System (ISO 9001:2015) and the Environmental Management System (ISO 14001:2015). At the same time, it is actively working toward certification for the Occupational Health and Safety Management System (ISO 45001:2018). The quality system is built upon the framework of IATF 16949, starting from customer requirements, with full employee participation and total quality management. The company is fully committed to implementing the requirements of the ISO 14001:2015 environmental management system, and is also advancing digital transformation and low-carbon transformation initiatives.
During the product development process, all potential hazards and the risks arising from them have been identified as comprehensively as possible. These hazards may originate from product design, methods of use, environmental factors, and even user operational errors. Each hazard must be clearly described and subjected to risk assessment. Through risk control measures, including electrical safety design, ergonomic mechanical design, and evaluation of optical source hazards, risks are reduced to an acceptable level. This is achieved through design improvements, the addition of protective measures, or modifications to user operating procedures. The residual risk remains within an acceptable range. In addition, risk management is a continuous process; therefore, throughout the product life cycle, ongoing monitoring and user satisfaction surveys are conducted to achieve continuous improvement objectives.
Formosa Biomedical Technology regularly conducts customer satisfaction surveys under its ISO quality system. The scope of these surveys covers multiple aspects, including product quality, pricing, after-sales service, and product development potential. Guided by the principles of C.P.I.P., the company cares for consumers, reviews feedback, and implements continuous improvements in order to provide high-quality customer service. Formosa Biomedical Technology also provides customer service hotlines and email support, and utilizes social media platforms to respond to consumers in real time.
This product has been granted a PCT patent and a patent in the Republic of China (Taiwan) (I852700).
