510(k) K050129
K050129 is an FDA 510(k) premarket notification submitted by Celleration, Inc. for the device "CELLERATION MIST THERAPY SYSTEM 5.1". The FDA issued a decision of Substantially Equivalent on May 17, 2005. The device falls under product code NRB (Wound Cleaner, Ultrasound), a Class II device regulated under 21 CFR 878.4410. Celleration, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2005
- Date Received
- January 19, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Cleaner, Ultrasound
- Device Class
- Class II
- Regulation Number
- 878.4410
- Review Panel
- SU
- Submission Type
The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound