EUFOTON SRL

Eufoton Srl specializes in manufacturing general/multiple surgical diode laser systems, such as the LASEMAR series and variants like the LASEmaR mini 800 and LASEmaR 1064. These devices are designed for precise laser energy delivery across multiple medical applications, including dermatological treatments, soft tissue surgery, and other clinical procedures. The company also produces specialized models like the EFLM-ME-03A-S50, tailored for specific surgical needs with customizable laser parameters.

Eufoton Srl is based in Italy, which means its devices must comply with EU Medical Device Regulations (MDR) and other relevant European standards. Since the company’s products are listed in the EU’s eudamed database, this confirms their registration under EU regulatory frameworks. Additionally, their devices are also included in the FDA’s UDI system, demonstrating adherence to international traceability requirements.

Eufoton Srl’s devices are classified as Class II, Class IIa, and Class IIb under EU medical device regulations. This classification determines the level of risk and regulatory scrutiny they undergo—Class II devices require additional safety and performance evaluations compared to lower-risk classes. The classification ensures that higher-risk devices, like surgical lasers, undergo rigorous testing and documentation to protect patient safety before authorization.

Eufoton Srl’s devices are listed in eudamed (the EU’s medical device registry) and the FDA’s Unique Device Identifier (UDI) system. This means their products are officially tracked for traceability, compliance, and transparency in both European and U.S. markets. Users can verify device details, regulatory status, and manufacturer information through these databases, ensuring they are working with authorized and compliant medical equipment.