The following data is part of a premarket notification filed by Solta Medical with the FDA for Powerx Lipo System.
| Device ID | K190555 |
| 510k Number | K190555 |
| Device Name: | PowerX Lipo System |
| Classification | System, Suction, Lipoplasty |
| Applicant | Solta Medical 11720 North Creek Pkway N. Suite 100 Bothell, WA 98011 |
| Contact | Manal Morcos |
| Correspondent | Manal Morcos Manal Morcos, MS BME, MBA 400 Somerset Corporate Boulevard Bridgewater, NJ 08807 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2019-05-01 |