(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]