510(k) Report

Devices descending from DEN040004

7 later devices reach Celleration Mist Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050129Celleration Mist Therapy System 5.1Celleration, Inc.20056—
+2K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+2K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+3K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+3K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+3K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+4K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—