510(k) K131096
K131096 is an FDA 510(k) premarket notification submitted by Arobella Medical, LLC for the device "AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 16, 2014. The device falls under product code NRB (Wound Cleaner, Ultrasound), a Class II device regulated under 21 CFR 878.4410. Arobella Medical, LLC has at least 2 other 510(k) clearances on record.
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