Medical Device Manufacturer · IL , Yokneam

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

15 submissions · 15 cleared · Since 2019

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Inmode , Ltd. Gastroenterology & Urology ✕

1 devices

1-1 of 1

Linked clinical trials FDA-regulated device evidence

Regulatory consultants 510(k) submission support ecosystem

Hogan Lovells US LLP

A. Stein - Regulatory Affairs Consulting , Ltd.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026