Development of evaluation methods for the approval and review of Intense pulsed light (IPL).

This Intense pulsed light (IPL) is skin therapy medical device to remove infection and lesion. The market size of IPL has increased because of increasing device users such as doctors, nurses, engineers, patients. Thus, the number of IPL approvals by Ministry of Food and Drug Safety (MFDS) has increased. However, since there are no standard and guideline for evaluation of IPL performance and safety, it is need to develop the evaluation method of IPL performance and safety for petitioners and examiners who are having difficulties in approval and review. In this study, the criteria and methods for scientific evaluation of safety and performance of IPL are proposed to support approval and review, and it is expected to enhance the international competitiveness of domestic medical device industry and patient safety. To develop the evaluation methods of IPL, first, the types and information of IPL have been collected and analyzed, and relative international and domestic standard and FDA guidance have been studied. Second, drawn test items, criteria and methods were verified at medical device testing institute. Finally, the guideline for evaluation of IPL performance and safety was reviewed through a consultative body composed of academic, industrial, institute, and government experts.