Bio Cosmetics, S.L.

Bio Cosmetics, S.L. specializes in topical oral care products. Their primary offering is the Xerostom Saliva Substitute Gel, which is designed to alleviate dry mouth symptoms by providing temporary moisture to oral tissues. This product is classified as a Class II device under FDA regulations, indicating it poses moderate risk and requires compliance with specific controls to ensure safety and effectiveness.

Bio Cosmetics, S.L. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to U.S. regulatory requirements, including the FDA’s 510(k) pathway for clearance.

Bio Cosmetics, S.L.’s devices, such as the Xerostom Saliva Substitute Gel, are listed in the U.S. Food and Drug Administration’s (FDA) 510(k) database. This registry tracks Class II devices that have undergone the 510(k) premarket notification process, demonstrating compliance with FDA requirements before commercial distribution.

Bio Cosmetics, S.L.’s devices, including the Xerostom Saliva Substitute Gel, are classified as Class II under the FDA’s regulatory framework. This classification is based on the device’s intended use and associated risk level—Class II devices require special controls beyond general controls to ensure safety and performance, such as performance standards or post-market surveillance.