Our hair removal devices are FDA-cleared, meeting stringent U.S. standards for safety and effectiveness, allowing smooth access to the North American market and assuring customers of medical-grade quality. They are also CE-marked in compliance with the EU Medical Device Regulation (MDR), ensuring they meet European safety, health, and environmental standards. SEA HEART’s manufacturing system is ISO 13485 certified, reflecting global standards in quality management, production consistency, and risk control for medical devices. Additionally, our machines are RoHS compliant, minimizing hazardous substances to protect both users and the environment. Every device undergoes strict quality control, including multiple inspections and a 48-hour aging test before shipping, with full independent test reports and traceable serial numbers provided for transparency and reliability.