[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4410]

[Page 400]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E_Surgical Devices
 
Sec. 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 Sec. 878.1(e) for 
the availability of this guidance document.

[70 FR 67355, Nov. 7, 2005]

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