AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
FDA 510(k) clearance K131096 · decided 2014-05-16
Clearance details
- K-number
- K131096
- Device name
- AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
- Applicant
- Arobella Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-04-18
- Decision date
- 2014-05-16
- Days to decision
- 393 days
- Clearance type
- Traditional
- Product code
- NRB
- Device class
- 2
- Regulation number
- 878.4410
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator (K162721) | Alliqua Biomedical, Inc. | 2016-12-22 |
| ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR (K140782) | Celleration, Inc. | 2014-08-13 |
| SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES (K123980) | Misonix, Inc. | 2013-03-05 |
| MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 (K122246) | Celleration, Inc. | 2012-08-13 |
| MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES (K112782) | Misonix, Inc. | 2011-12-01 |
| AS 1000 ULTRASOUND WOUND THERAPY SYSTEM (K091038) | Arobella Medical, LLC | 2009-06-19 |
| CELLERATION MIST THERAPY SYSTEM 5.1 (K050129) | Celleration, Inc. | 2005-05-17 |
| CELLERATION MIST THERAPY SYSTEM (DEN040004) | Celleration | 2004-06-25 |
Recalls involving this device
No recalls on record reference this clearance.