Brera Medical, Inc.

Brera Medical, Inc. specializes in electrosurgical systems, specifically those that use plasma-based technology for precise tissue management during surgical procedures. Their primary focus is on devices like the Plasmage and Plasmage System, which are designed for controlled cutting and coagulation in operating environments.

Brera Medical, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s risk-based system. The U.S. regulatory framework ensures that devices like the Plasmage and Plasmage System must meet specific performance and safety standards before being authorized for market.

Brera Medical, Inc.’s devices, including the Plasmage and Plasmage System, are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. These registries confirm the devices’ classification as Class II and their compliance with U.S. regulatory requirements, ensuring traceability and transparency in the medical device supply chain.

Brera Medical, Inc.’s devices, such as the Plasmage and Plasmage System, are classified as Class II under FDA regulations. This classification indicates a moderate level of risk, requiring special controls beyond general controls to ensure safety and effectiveness. The classification influences the regulatory pathway, including pre-market submissions like the 510(k), which demonstrates that the devices meet established performance criteria for their intended use.