Analysis on the Current Situation of Regulations and Standards for Home Photoepilators / 中国医疗器械杂志

ABSTRACT

This article introduces the safety risks of the novel light-based home-use hair removal device, and analyzes the differences in regulation among China, the United States and the European Union. In China, household intense pulsed light hair removal devices will also be supervised in accordance with medical device regulations. Therefore, the safety standards adopted in the absence of specific regulations are no longer applicable to the new regulatory requirements. It is imperative to adopt the new standards available to home photoepilators, so as to ensure the safety and effectiveness of the approved devices.