Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4405](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4405) → QGM — Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

# QGM · Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

_General, Plastic Surgery · 21 CFR 878.4405 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM

## Overview

- **Product Code:** QGM
- **Device Name:** Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
- **Regulation:** [21 CFR 878.4405](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4405)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

The Edison System is a focused ultrasound system for non-thermal, mechanical tissue ablation. It uses high amplitude, short-duration focused ultrasound pulses to induce acoustic cavitation (a 'bubble cloud') at a focal location to mechanically destroy soft tissue, resulting in a homogenous acellular lysate. It is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors.

## Classification Rationale

Class II (special controls). The device is a focused ultrasound system for non-thermal, mechanical tissue ablation, classified under 21 CFR 878.4405.

## Special Controls

In combination with the general controls of the FD&C Act, the focused ultrasound system for non-thermal, mechanical tissue ablation is subject to the following special controls:

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241902](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM/K241902.md) | Edison System | HistoSonics, Inc. | Oct 30, 2024 | SESE |
| [K233466](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM/K233466.md) | Edison System | HistoSonics, Inc. | Mar 13, 2024 | SESE |
| [DEN220087](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM/DEN220087.md) | Edison System | HistoSonics, Inc. | Oct 6, 2023 | DENG |

## Top Applicants

- HistoSonics, Inc. — 3 clearances

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM)

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