K062544 is an FDA 510(k) clearance for the AR1000 ULTRASONIC WOUND THERAPY SYSTEM. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Arobella Medical, LLC (Carmel, US). The FDA issued a Cleared decision on January 3, 2007, 126 days after receiving the submission on August 30, 2006.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K062544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2006 |
| Decision Date | January 03, 2007 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |