SERENA SLEEP SOLUTIONS LLC

Serena Sleep Solutions LLC specializes in reusable oral appliances for managing sleep-disordered breathing. Their primary products include mandible-repositioning orthoses, which reposition the jaw to improve airflow during sleep, and mouthguards designed to protect teeth. Examples include customizable devices like the Versa, Nylon Nightguard, and specialized appliances such as the Elevate and Flex. These are intended for oral use and address conditions related to sleep breathing.

Serena Sleep Solutions LLC is based in the United States. Their devices are regulated under U.S. medical device frameworks, which classify them as either Class II or Unclassified based on their intended use and risk profile. This means their products fall under the jurisdiction of U.S. regulatory authorities, ensuring compliance with local standards for safety and performance.

Serena Sleep Solutions LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for tracking medical devices in the United States, allowing healthcare providers, regulators, and patients to access standardized information about the devices’ identification, classification, and compliance status.

Serena Sleep Solutions LLC’s devices are classified as either Class II or Unclassified under U.S. regulatory frameworks. Class II devices generally pose moderate risk and require special controls to ensure their safety and effectiveness, while Unclassified devices may have lower risk or be exempt from certain regulatory requirements. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.