VIVO SURGICAL PRIVATE LIMITED

Vivo Surgical Private Limited specializes in internal lighting devices used during open surgical procedures. Their primary focus is on enhancing visibility within surgical sites, with the KLARO In Vivo Surgical Lighting system as their flagship product. These devices are designed to illuminate internal areas where direct external lighting is insufficient.

Vivo Surgical Private Limited is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing operations, and customer support, as it aligns with FDA oversight and UDI listing requirements.

Vivo Surgical Private Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details and compliance status.

Vivo Surgical Private Limited’s devices fall under the FDA’s Class II regulatory category. This classification is based on the risk associated with the device—Class II devices generally pose moderate risk and require special controls in addition to general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.