K041058 is an FDA 510(k) clearance for the MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS. This device is classified as a System, Suction, Lipoplasty For Removal (Class II - Special Controls, product code QPB).
Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 17, 2004, 24 days after receiving the submission on April 23, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5040. A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring.
| 510(k) Number | K041058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2004 |
| Decision Date | May 17, 2004 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QPB — System, Suction, Lipoplasty For Removal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5040 |
| Definition | A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring |