Solta Medical Liposonix

Liposonix is a cart-based high intensity focused ultrasound (HIFU) system that delivers focused energy into the fat layer under the skin without incisions. It was developed by Medicis Technologies of Bothell, Washington. FDA cleared the LipoSonix system Model 1 on August 19, 2011 under K100874, and Model 2 on October 20, 2011 under K112626. Both are cleared for noninvasive waist circumference reduction, under the product code for focused ultrasound for aesthetic use. In September 2011 Medicis sold its rights to the system to Solta Medical, which is why most units carry the Solta name.

The two models are built differently. In Model 1, the base, a treatment head containing the transducer and a treatment arm form one unit. Model 2 uses a cart, a detachable handpiece and a user interface display. FDA's device identifier records for Solta list these Model 2 parts: a handpiece assembly, a replacement handpiece, a replaceable treatment cartridge, 1.3 cm treatment kits including an extended use version, a WiFi system module and a Model 2 installation kit. The cleared labeling excludes patients with less than 1.0 cm of fat beyond the selected focal depth.

The fastest way to tell the generations apart is whether the transducer sits in a fixed head on an arm (Model 1) or in a handpiece that unplugs from the cart (Model 2). It is also distinct from the Ulthera System, the ultrasound device FDA cited as its predicate.

A buyer will ask which model you have and for the serial label. Other questions are whether the handpiece or treatment head has visible damage, how many treatment cartridges and kits come with it and how old they are, and whether the system starts without errors. Software version, recent service records and the condition of the cart and display also matter. Photos of the label, the screen at startup and every accessory help a dealer make a firm offer.