---
kind: "section"
citation: "21 C.F.R. § 878.4410"
title: "21"
number: "878.4410"
heading: "Low energy ultrasound wound cleaner."
url: "https://uscodex.org/cfr/21/878.4410"
---

# §878.4410. Low energy ultrasound wound cleaner.

- (a) **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.
- (b) **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)](/cfr/21/878.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[70 FR 67355, Nov. 7, 2005]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[70 FR 67355, Nov. 7, 2005]