Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4410](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4410) → NRB — Wound Cleaner, Ultrasound

# NRB · Wound Cleaner, Ultrasound

_General, Plastic Surgery · 21 CFR 878.4410 · Class 2_

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

## Overview

- **Product Code:** NRB
- **Device Name:** Wound Cleaner, Ultrasound
- **Regulation:** [21 CFR 878.4410](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4410)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **3rd-party reviewable:** yes

## Identification

A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.

## Classification Rationale

Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K162721](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K162721.md) | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator | Alliqua Biomedical, Inc. | Dec 22, 2016 | SESE |
| [K140782](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K140782.md) | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | Celleration, Inc. | Aug 13, 2014 | SESE |
| [K131096](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K131096.md) | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | Arobella Medical, LLC | May 16, 2014 | SESE |
| [K123980](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K123980.md) | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | Mar 5, 2013 | SESE |
| [K122246](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K122246.md) | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 | Celleration, Inc. | Aug 13, 2012 | SESE |
| [K112782](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K112782.md) | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | Dec 1, 2011 | SESE |
| [K091038](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K091038.md) | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | Arobella Medical, LLC | Jun 19, 2009 | SESE |
| [K050129](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/K050129.md) | CELLERATION MIST THERAPY SYSTEM 5.1 | Celleration, Inc. | May 17, 2005 | SESE |
| [DEN040004](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/DEN040004.md) | CELLERATION MIST THERAPY SYSTEM | Celleration | Jun 25, 2004 | DENG |

## Top Applicants

- Celleration, Inc. — 3 clearances
- Misonix, Inc. — 2 clearances
- Arobella Medical, LLC — 2 clearances
- Celleration — 1 clearance
- Alliqua Biomedical, Inc. — 1 clearance

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

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