Tianjin Mastervision Technology Co., Ltd.

Tianjin Mastervision Technology Co., Ltd. specializes in rigid-gas-permeable (RGP) contact lenses designed for daily wear. These include standard and customised options like scleral lenses, as well as bespoke lenses tailored for specific corneal conditions. Their portfolio also includes fluoroxyfocon A-based RGP lenses, which are engineered for enhanced oxygen permeability and precision fitting.

Tianjin Mastervision Technology Co., Ltd. is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company’s products are listed in the FDA’s 510(k) and UDI registries, they are subject to U.S. medical device classification standards, specifically Class II, which applies to devices posing moderate risk.

Tianjin Mastervision Technology Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) registry. Inclusion in the 510(k) program demonstrates that the company has submitted evidence to the FDA that its devices are substantially equivalent to legally marketed predicate devices. The UDI registry ensures traceability and transparency in the supply chain, which is critical for tracking devices throughout their lifecycle.

Tianjin Mastervision Technology Co., Ltd.’s devices are classified as Class II under regulatory frameworks like the FDA’s system. This classification indicates that the lenses pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) submissions to demonstrate equivalence to existing approved devices, ensuring they meet regulatory standards before reaching the market.