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) → NRJ — Ultrasound, Skin Permeation

# NRJ · Ultrasound, Skin Permeation

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

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

## Overview

- **Product Code:** NRJ
- **Device Name:** Ultrasound, Skin Permeation
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K040525](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRJ/K040525.md) | SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 | Sontra Medical, Inc. | Aug 17, 2004 | SESK |

## Top Applicants

- Sontra Medical, Inc. — 1 clearance

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

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