Insightec , Ltd. - FDA 510(k) Cleared Devices

Insightec, Ltd. is a medical device company specializing in Gastroenterology & Urology devices, with a manufacturing facility in Tirat Carmel, IL. The company develops focused ultrasound technology for precision surgical applications.

Insightec has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory activity occurred in 2023. This represents a historical record, as the company has not received clearances in more than five years.

The company's cleared devices include the Exablate Model 2100V1, Exablate Prostate System, and Exablate MRgFUS platform. These systems represent the company's core focus on MRI-guided focused ultrasound for targeted tissue ablation in gastroenterology and urology applications.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Insightec, Inc. as regulatory consultant.