FISIOLINE SRL

Fisioline Srl specializes in laser-based medical devices primarily for skin treatments. Their portfolio includes handheld laser handpieces, such as the LASER HANDPIECE, along with various fiber and lensholder terminals designed for precision applications. Examples include the Zoom Terminal (available in diameters from 8mm to 25mm), Focalized Terminal, and specialized systems like LUMIX CW and LUMIX variants (e.g., LUMIX 250, LUMIX 2). These devices are tailored for controlled energy delivery in dermatological procedures.

Fisioline Srl is based in Italy. Their devices are registered in two key regulatory databases: the EU’s EUDAMED system, which tracks medical devices authorized under EU Medical Device Regulations, and the U.S. FDA’s Unique Device Identification (UDI) system. Registration in these databases ensures compliance with applicable regulatory requirements for their product categories.

Fisioline Srl’s devices are classified under the EU Medical Device Regulations as Class II, Class IIa, or Class IIb. The classification depends on the risk associated with each device’s intended use. For example, devices like the Zoom Terminal or LUMIX systems, which involve precision energy delivery for skin treatments, fall into these higher-risk categories due to their potential impact on patient safety and performance requirements.

Yes, Fisioline Srl’s devices are listed in two international regulatory registries: eudamed (the EU’s database for medical devices) and the FDA’s UDI system (for tracking devices in the U.S.). Listing in these systems confirms that their products meet the necessary regulatory standards for distribution in those markets, though individual device authorization depends on local approval processes.