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InMode RF System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163190

by Inmode MD , Ltd.

Identifiers

510(k) Number
K163190 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The InMode RF System is a computerized device classified as a Radiofrequency (RF) Generator (Product Code: GEI) under the FDA’s General, Plastic Surgery advisory committee. It delivers controlled radiofrequency energy for electrocoagulation and hemostasis, incorporating real-time temperature and impedance monitoring to ensure precise and safe tissue heating during surgical procedures.

The system is supplied as a reusable medical device, featuring a main platform with integrated power supply, RF generator, controller, and display panel. It operates in regulated clinical settings, adhering to FDA clearance (K163190) under a Special 510(k) pathway. No sterility or single-use specifications are noted, and MRI safety is not addressed in the available data. The device is manufactured by Inmode MD, Ltd., based in Yokneam, Israel.

Frequently asked questions

What clinical procedures is the InMode RF System designed to assist with, and how does it ensure safety during use?

The InMode RF System is designed for electrocoagulation and hemostasis during surgical procedures, particularly in general and plastic surgery settings. It delivers controlled radiofrequency energy while monitoring real-time temperature and impedance to ensure precise and safe tissue heating, reducing the risk of unintended damage.

Is the InMode RF System intended for single-use or reusable applications, and how is it supplied?

The InMode RF System is supplied as a reusable medical device. It consists of a main platform that integrates the power supply, RF generator, controller, and display panel, all of which are intended for repeated use in regulated clinical environments.

What regulatory pathway was followed for FDA clearance of the InMode RF System, and what does this classification mean for its intended use?

The InMode RF System received FDA clearance under the Special 510(k) pathway, classified as a Radiofrequency (RF) Generator (Product Code: GEI) under the General, Plastic Surgery advisory committee. This classification means it was determined to be substantially equivalent to a legally marketed device and is authorized for use in controlled clinical settings for electrocoagulation and hemostasis.

Does the InMode RF System come with any sterility guarantees, and how should it be stored between uses?

The available data does not specify sterility requirements or single-use constraints for the InMode RF System. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be followed as per clinical guidelines to ensure safe reuse between procedures. Storage should adhere to manufacturer-recommended conditions to preserve functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: InMode RF System by Inmode MD Ltd. | FDA 510 (k) Summary, PDF InMode MD Ltd. a - Food and Drug Administration, PDF July 24, 2024 InMode Ltd. - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inmode MD , Ltd.

Sources (1)

  • FDA 510(k) K163190 24 fields · synced Sep 20, 2026