Uplevity, Inc.

Uplevity, Inc. specializes in phototherapy lamps that emit blue, red, and infrared light for medical applications. These devices are designed to deliver targeted light therapy, such as the NURYSH and LYFT models, which are intended for specific therapeutic uses.

Uplevity, Inc. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under the FDA’s jurisdiction, they are required to comply with U.S. medical device laws, including registration, listing, and classification requirements.

Uplevity’s devices are classified as Class II medical devices by the FDA. This classification indicates a moderate level of risk, requiring specific controls to ensure safety and effectiveness. Class II devices typically undergo premarket notification (510(k)) submissions to demonstrate substantial equivalence to a predicate device, ensuring they meet regulatory standards before entering the market.

Uplevity’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) listing confirms that the device has undergone FDA review to demonstrate compliance with applicable regulations, while the UDI listing ensures traceability and identification of the device throughout its lifecycle, supporting patient safety and regulatory tracking.