AYON Body Contouring System (AYON SYSTEM)

The AYON Body Contouring System is an ultrasound-assisted liposuction device intended for fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for aesthetic body contouring. It comprises three sub-systems: an ultrasound sub-system for tissue fragmentation, an infiltration sub-system for fluid delivery, and an aspiration sub-system for tissue removal, with the infiltration and aspiration functions capable of operating independently.

The AYON operates at 37 kHz nominal frequency with three power settings (8, 20, and 28 watts) and uses piezoelectric crystal transducers with titanium alloy probes ranging 2.2–3.7 mm in diameter and 18–33 cm in length. It features a single touchscreen interface with graphical controls, adjustable infiltration flow rates of 40–1000 mL/min, and suction vacuum of 27 in Hg at sea level. The predicate VASER 2.1 operates at 36 kHz with variable 10–100% amplitude settings, broader probe sizes (1.0–6.0 mm diameter, 7–40 cm length), and knob/dial controls with different infiltration and suction specifications.

ISO 10993-1 (biocompatibility), ISO 10079-1 and ISO 10079-4 (aspiration subsystems), ISO 17665 (reprocessing of sterile products), ISO 62304 (software verification and validation), IEC 60601-1-1 (electrical safety), IEC 60601-1-2 and IEC 60601-4-2 (electromagnetic compatibility), and wireless emissions testing for the footswitch.

Both devices share identical intended use (aesthetic body contouring via fragmentation and emulsification of subcutaneous fat), identical mechanism of action (ultrasound fragmentation combined with infiltration and aspiration), and identical electrical classification (IEC Class I, Type BF). Minor technological differences—such as the AYON's centralized touchscreen interface versus the predicate's distributed knobs, slightly higher operating frequency (37 vs. 36 kHz), narrower probe diameter range, and higher infiltration flow rates—do not impact safety or function because comparative bench testing demonstrated they do not affect substantial equivalence. The AYON's suction vacuum and infiltration rates fall within or below the ranges of other FDA-cleared devices, confirming safety and performance parity with the predicate.