# mJOULE System and Accessories

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/mjoule-system-and-accessories-gex>
- Manufacturer: [Sciton, Inc](https://devicerts.com/manufacturers/fda-fei-3001415984) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: GEX

## Overview

*AI-generated summary, 2026-09-23. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The mJOULE System and Accessories is a device used in general and plastic surgery procedures. It is substantially equivalent to a legally marketed device as determined by FDA 510(k) clearance.

The system is supplied by Sciton, Inc and was cleared via the traditional 510(k) pathway under product code GEX. It received FDA clearance on April 15, 2022, under K213350.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K213350 · decision 2022-04-15 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K213350 [FDA 510(k)]
- FDA product code: GEX [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: mJOULE System and Accessories, Sciton, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/mjoule-system-and-accessories-gex (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/mjoule-system-and-accessories-gex.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/mjoule-system-and-accessories-gex
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.