510(k) K261361

TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet) by Carl Zeiss Meditec, AG — Product Code LFL

K261361 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)". The FDA issued a decision of Substantially Equivalent on Oct 15, 2026. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Carl Zeiss Meditec, AG has 76 other 510(k) clearances on record.