Application of Performance Test Method in Korea for LED Optical Medical Device Samples

Abstract

AbstractThe development of light-based technologies has facilitated the use of phototherapy devices in the medical field. Representative phototherapy devices are laser surgical instruments and medical laser irradiators. While the former are used for the removal, ablation, and destruction of areas in need of treatment using the light of a strong laser; the latter irradiate the skin, induce skin regeneration, and relieve pain [1]. These medical devices are used under the guidance of healthcare providers in medical institutions and can be hazardous because they use strong light. According to the Korean Ministry of Food and Drug Safety, medical devices are divided into four classes according to the hazard level [2]. Devices such as lasers are currently represented by Class 3, which represents a high risk. However, various personal phototherapy devices have recently emerged and are used without any instructions from healthcare providers. Among them, representative personal phototherapy devices include those that use LED. Such devices are known to have effects such as pain and inflammation relief, scar healing, and skin regeneration according to previous studies [3]. With the progress of research, LED medical devices for skin improvement and beauty treatment are emerging in Korea. Thus, LED medical devices are used for various purposes. Certain devices only use LEDs, while others are used in com-bination with lasers their boundary with medical laser irradiators is vague. Based on the report on personal phototherapy devices by the Korea Consumer Agency, there were 172 adverse events of LED masks, which were home phototherapy devices, from 2018 to Au-gust 2020; they comprise 134 cases of skin and subcutaneous tissue injuries, six of burns, one of heat sensation and dyspnoea, and one of bruising [4]. As various phototherapy de-vices continue to be developed, assuring adequate safety is paramount. This study con-tributes to the industrial development of LED phototherapy devices and new phototherapy devices. We derived a performance test method to ensure safety related to the performance of LED phototherapy devices in the Korean context.