Teoxane SA

Teoxane SA specializes in dermal tissue reconstructive materials derived from microbes, designed for soft tissue augmentation and facial rejuvenation. These products are formulated for use under local anaesthesia and include variations like RHA® 2, RHA® Redensity™ Mepi, and other numbered formulations (e.g., RHA® 3, RHA® 4). The materials are intended to restore volume and improve skin texture in cosmetic procedures.

Teoxane SA is headquartered in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class III classification, they require premarket approval (PMA)—the highest regulatory standard for devices with substantial risk. This ensures rigorous evaluation of safety and effectiveness before commercialization.

Teoxane SA’s devices are included in the FDA’s Unique Device Identifier (UDI) database, a publicly accessible registry that tracks medical devices for traceability and compliance. Listing in the UDI system is mandatory for Class III devices in the US, ensuring transparency in the supply chain and adherence to regulatory requirements.

Teoxane SA’s dermal reconstructive materials are classified as Class III because they are intended for permanent implantation or life-supporting/sustaining procedures, even though they are used in cosmetic applications. Under FDA guidelines, such devices require premarket approval (PMA) due to their potential risks, ensuring they meet strict safety and efficacy standards before patient use.

Teoxane SA’s microbe-derived dermal reconstructive materials are designed for soft tissue augmentation, primarily in facial rejuvenation and volume restoration. They are injected under local anaesthesia to fill wrinkles, restore lost volume, or enhance facial contours. The formulations vary in density (e.g., RHA® Redensity™ Mepi for deeper layers) to address specific aesthetic concerns.