K190555 is an FDA 510(k) clearance for the PowerX Lipo System. This device is classified as a System, Suction, Lipoplasty For Removal (Class II - Special Controls, product code QPB).
Submitted by Solta Medical (Bothell, US). The FDA issued a Cleared decision on May 1, 2019, 57 days after receiving the submission on March 5, 2019.
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 | K190555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2019 |
| Decision Date | May 01, 2019 |
| Days to Decision | 57 days |
| Submission Type | Special |
| 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 |