21 C.F.R. § 878.4410 Low energy ultrasound wound cleaner.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices
§ 878.4410 Low energy ultrasound wound cleaner.
