510(k) K112782

MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES by Misonix, Inc. — Product Code NRB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 1, 2011
Date Received: September 26, 2011
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

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