Identifiers
- 510(k) Number
- K201150 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 Multi-System is a medical device that employs radiofrequency (RF) energy for various applications. It is compatible with fractional RF applicators and non-invasive RF applicators, including Forma (Plus), WMface, and related accessories.
The device is supplied as a reusable system and received FDA 510(k) clearance (K201150) on 2020-07-22 under product code GEI. It is manufactured by InMode, Ltd. and intended for use in general and plastic surgery settings as indicated by the advisory committee classification.
Frequently asked questions
What is the InMode RF Multi-System used for?
The InMode RF Multi-System is intended for use in general and plastic surgery settings, as indicated by its advisory committee classification. It employs radiofrequency energy and is compatible with fractional and non-invasive RF applicators such as Forma (Plus) and WMface for various applications.
How is the InMode RF Multi-System supplied and is it reusable?
The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance between procedures, as stated in the device description.
What regulatory pathway was used for the InMode RF Multi-System and what was the outcome?
The InMode RF Multi-System received FDA 510(k) clearance through the traditional pathway, with the decision describing it as substantially equivalent to a predicate device, based on the provided authorization and decision details.
What product code and classification apply to the InMode RF Multi-System?
The device is classified under product code GEI and was reviewed by the advisory committee with description 'General, Plastic Surgery', which reflects the clinical panel involved in its evaluation, not a direct indication of use.
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 Multi-System (K201150) — FDA 510 (k) | Innolitics, PDF Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting ..., InMode RF Multi-System — FDA 510 (k) K201150 | MedTracker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201150 | Class II | Active |
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Manufacturer
- Manufacturer
- InMode , Ltd.
Sources (1)
- FDA 510(k) K201150 24 fields · synced Sep 19, 2026