Auragen Aesthetics, LLC

Auragen Aesthetics, LLC specializes in devices for the non-invasive processing of autologous adipose tissue, which is fat derived from the patient’s own body. Their primary focus is on systems like the AuraGen Aesthetics and the AuraGen 123 Suction Lipoplasty System (A123), designed for suction lipoplasty and subsequent preparation of fat cells for reinjection in aesthetic procedures. These devices streamline the extraction, processing, and reinjection workflows to support fat transfer treatments.

Auragen Aesthetics, LLC is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s risk-based framework. The FDA’s oversight ensures that devices like those from Auragen meet safety and performance standards before they are authorized for use in clinical settings.

Auragen Aesthetics’ devices are classified as Class II under FDA regulations. This classification indicates a moderate level of risk, requiring special controls beyond general controls to ensure their safety and effectiveness. Class II devices typically undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory requirements before commercial distribution.

Auragen Aesthetics’ devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) database provides details about the premarket submission process and equivalence claims, while the UDI system assigns a unique identifier to each device, improving traceability, safety monitoring, and regulatory compliance. These registries help healthcare providers and regulators verify device authorization and track compliance.