CELLERATION MIST THERAPY SYSTEM
Device Facts
| Record ID | DEN040004 |
|---|---|
| Device Name | CELLERATION MIST THERAPY SYSTEM |
| Applicant | Celleration |
| Product Code | NRB · General, Plastic Surgery |
| Decision Date | Jun 25, 2004 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 878.4410 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
