21 CFR § 878.4410 - Low energy ultrasound wound cleaner.

---
identifier: "/us/cfr/t21/s878.4410"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4410 - Low energy ultrasound wound cleaner."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4410"
section_name: "Low energy ultrasound wound cleaner."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 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) for the availability of this guidance document.

[70 FR 67355, Nov. 7, 2005]