Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

The Piezomed Pro is an ultrasonic surgical system that converts electrical energy into mechanical vibrations to perform osteotomies, osteoplasties, drilling, and shaping of hard tissue. It is indicated for use in otolaryngology, maxillofacial surgery, hand and foot surgery, and plastic and reconstructive surgery. The system consists of a control module (M-PM100), handpiece (M-PH350), various interchangeable tips, and accessories, and must be connected to W&H's AMADEO device to function.

The device uses piezoelectric ultrasonic technology operating at 22-35 kHz with a frequency of 50-60 Hz in intermittent mode. It features adjustable oscillation amplitude (5-100% in 5% steps) and coolant flow control (5-100% in 5% steps) via a foot pedal. The handpiece contains a piezoelectric transducer that converts electrical signals into mechanical micro-vibrations transmitted to interchangeable surgical tips. Electrical classification is Class I, Type B per IEC 60601-1.

ISO 10993-1 (biocompatibility evaluation), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ISO 10993-12 and ISO 10993-18 (chemical characterization), IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), ISO 18398 (falling and vibration testing), ISO 21530 (resistance to disinfectants), and IEC 62304 (software validation).

The Piezomed Pro is substantially equivalent because it shares identical intended use (osteotomies, osteoplasties, drilling, and bone shaping across the same surgical specialties), operating principles (piezoelectric ultrasonic conversion of electrical energy to mechanical vibration), and technological characteristics as the predicate Piezosurgery Plus (K153743). Both devices use the same basic function, frequency range, intermittent operation mode, and component design. Performance testing confirms the device meets the same specifications, and biocompatibility and electrical safety testing demonstrate no new safety or effectiveness issues compared to the legally marketed predicate.