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510(k) K131096

AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM by Arobella Medical, LLC — Product Code NRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2014
Date Received
April 18, 2013
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

Other clearances by Arobella Medical, LLC

  • K091038 — AS 1000 ULTRASOUND WOUND THERAPY SYSTEM (June 19, 2009)
  • K062544 — AR1000 ULTRASONIC WOUND THERAPY SYSTEM (January 3, 2007)

Other clearances for product code NRB

  • K162721 — Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicato (December 22, 2016)
  • K140782 — ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLI (August 13, 2014)
  • K123980 — SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES (March 5, 2013)
  • K122246 — MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF (August 13, 2012)
  • K112782 — MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES (December 1, 2011)
  • K091038 — AS 1000 ULTRASOUND WOUND THERAPY SYSTEM (June 19, 2009)
  • K050129 — CELLERATION MIST THERAPY SYSTEM 5.1 (May 17, 2005)
  • DEN040004 — CELLERATION MIST THERAPY SYSTEM (June 25, 2004)