K131096 is an FDA 510(k) clearance for the AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM. This device is classified as a Wound Cleaner, Ultrasound (Class II - Special Controls, product code NRB).
Submitted by Arobella Medical, LLC (Minnetonka, US). The FDA issued a Cleared decision on May 16, 2014, 393 days after receiving the submission on April 18, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4410. 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.
| 510(k) Number | K131096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2013 |
| Decision Date | May 16, 2014 |
| Days to Decision | 393 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NRB — Wound Cleaner, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4410 |
| Definition | 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 |