Sonicone Plus Ultrasound Wound Care System and Accessories
FDA 510(k) K123980 · Misonix, Inc.
510(k) numberK123980
Submission
- Device name
- Sonicone Plus Ultrasound Wound Care System and Accessories
- Applicant
- Misonix, Inc.
Farmingdale, NY, US - Received
- December 26, 2012
- Decision date
- March 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRB – Wound Cleaner, Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4410
- Specialty
- General, Plastic Surgery
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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|---|---|---|---|
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorNRB · Special | Alliqua Biomedical, Inc. | 12/22/2016SE |
| K140782 | Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist ApplicatorNRB · Traditional | Celleration, Inc. | 08/13/2014SE |
| K131096 | AR1000 Series Ultrasonic Wound Therapy SystemNRB · Traditional | Arobella Medical, LLC | 05/16/2014SE |
| K122246 | Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12NRB · Special | Celleration, Inc. | 08/13/2012SE |
| K112782 | Misonix Sonicone(R) Ultrasonic Wound Care System and AccessoriesNRB · Traditional | Misonix, Inc. | 12/01/2011SE |
| K091038 | AS 1000 Ultrasound Wound Therapy SystemNRB · Traditional | Arobella Medical, LLC | 06/19/2009SE |
| K050129 | Celleration Mist Therapy System 5.1NRB · Traditional | Celleration, Inc. | 05/17/2005SE |
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|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/30/2026SE |
| K221235 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/28/2022SE |
| K212060 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 12/13/2021SE |
| K190160 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | 05/30/2019SE |
| K112782 | Misonix Sonicone(R) Ultrasonic Wound Care System and AccessoriesNRB · Traditional | 12/01/2011SE |
| K070779 | Sonatherm 600I Ultrasonic Lesion Generating SystemNTB · Traditional | 07/09/2008SE |
| K070313 | Misonix, Inc., AUSS-7 Ultrasonic Surgical Aspirator SystemLFL · Special | 05/11/2007SE |
| K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RFLFL · Traditional | 10/26/2006SE |
| K042096 | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemNTB · Traditional | 01/26/2006SE |
| K052702 | Misonix Inc. FS-1000-RF Bipolar Forceps AccessoryGEI · Traditional | 11/21/2005SE |
Questions and answers
When was Sonicone Plus Ultrasound Wound Care System and Accessories cleared by the FDA?
Sonicone Plus Ultrasound Wound Care System and Accessories (K123980) received a 510(k) decision of Substantially Equivalent on March 5, 2013, 69 days after the submission was received.
What is the product code of K123980?
The FDA product code is NRB – Wound Cleaner, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 878.4410.