Shanghai Wonderful Opto-Electrics Tech.Co., Ltd

Shanghai Wonderful Opto-Electrics Tech.Co., Ltd specializes in diode laser systems for medical and cosmetic applications. Their portfolio includes dental diode laser systems, used for precision procedures in dentistry, and dermatological diode laser systems, designed for soft tissue treatments and cosmetic dermatology. These devices are tailored for controlled energy delivery in clinical settings.

The company is based in the United States, though its name suggests origins in Shanghai, China. The regulatory and commercial focus for its devices aligns with U.S. markets and requirements, including UDI compliance.

The company’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry is mandatory for Class II devices in the U.S., ensuring traceability and compliance with FDA requirements for medical devices.

The company’s devices fall under Class II classification in the U.S. This classification applies to devices with moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices are subject to stricter regulatory oversight, including UDI requirements, to mitigate potential risks.