510(k) K231378

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 by Insightec, Ltd. — Product Code PLP

K231378 is an FDA 510(k) premarket notification submitted by Insightec, Ltd. for the device "Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0". The FDA issued a decision of Substantially Equivalent on October 30, 2023. The device falls under product code PLP (High Intensity Ultrasound System For Prostate Tissue Ablation), a Class II device regulated under 21 CFR 876.4340. Insightec, Ltd. has at least 1 other 510(k) clearance on record.