Biotec Italia, Srl

Biotec Italia, Srl specializes in light-energy skin surface treatment system applicators, such as the XLase Plus. These devices are designed for cosmetic or medical skin resurfacing, delivering controlled energy to the skin’s surface to address issues like pigmentation or texture irregularities. The technology focuses on promoting skin renewal through targeted light wavelengths.

Biotec Italia, Srl is based in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under Class II classification, they require premarket notification (510(k)) clearance and must include a Unique Device Identifier (UDI) in the FDA’s databases. This classification reflects moderate risk, necessitating specific documentation and registration processes.

Biotec Italia, Srl’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and compliance with U.S. medical device regulations, confirming that the devices meet required safety and performance standards before market distribution.

Biotec Italia, Srl’s devices, such as the XLase Plus, are classified as FDA Class II. This classification is assigned based on the device’s intended use and risk level—moderate risk in this case—requiring premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device. Class II also mandates compliance with UDI requirements to track and trace devices throughout their lifecycle.