Lipsonix(r) System Model 2

K112626 is the FDA 510(k) clearance record for LIPSONIX(R) SYSTEM MODEL 2, a class II device, cleared for Medicis Technologies Corporation on 2011-10-20 under FDA product code OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption). FDA's definition for product code OHV reads: "A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for...". FDA records list 2 510(k) clearances for Medicis Technologies Corporation, from 2011-08-19 to 2011-10-20. As of 2026-09-10, FDA records show no recalls naming K112626.