PAL Aspiration System

The PAL Aspiration System is a suction-assisted aesthetic body contouring device consisting of a modular dual-piston pump unit, electronic control console, and optional accessories. It provides an adjustable vacuum source (0-29 inHg) to drive tissue suction during cosmetic procedures, with digital pressure control and monitoring capabilities.

The subject device uses a two-cylinder piston pump like the predicate but differs in display technology (non-touchscreen LCD vs. vacuum gauge with LED), pressure control (knob plus optional programmable switches vs. knob only), footswitch type (dual electric vs. air-powered), maximum vacuum (29 vs. 27.5 inHg), and maximum flow rate (2.12 cfm vs. 6.4 cfm). Both devices have similar housing materials, filter ports, and safety features.

Electrical safety per IEC 60601-1; electromagnetic disturbance testing per IEC 60601-1-2 and IEC 60601-4-2; essential performance per IEC 60601-1-6; software verification per IEC 62304; usability testing per IEC 62366-1; safety testing for electrically powered suction pumps per ISO 10079-1; and bench testing for vacuum performance, free air flow, noise, and reliability.

Both devices share identical indications for use (aesthetic body contouring), same FDA classification (Class II, product code QPB), and the same fundamental mechanism (dual-piston pump vacuum source). The differences in display, control interface, and flow rate specifications do not raise new safety or effectiveness questions because the subject device passed all non-clinical bench testing and complies with the same applicable consensus standards, demonstrating functionally equivalent capabilities for its intended aesthetic contouring application.