510(k) K123980

SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES by Misonix, Inc. — Product Code NRB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 5, 2013
Date Received: December 26, 2012
Clearance Type: Special
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

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K050129 — CELLERATION MIST THERAPY SYSTEM 5.1 (May 17, 2005)
DEN040004 — CELLERATION MIST THERAPY SYSTEM (June 25, 2004)