The following data is part of a premarket notification filed by Lipogems International Spa with the FDA for The Lipogems System.
| Device ID | K142682 |
| 510k Number | K142682 |
| Device Name: | The Lipogems System |
| Classification | System, Suction, Lipoplasty |
| Applicant | Lipogems International SpA viale Bianca Maria 24 Milano, IT 20129 |
| Contact | Carlo Russo |
| Correspondent | Roger Gray DONAWA LIFESCIENCE CONSULTING Srl PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2014-12-22 |
| Summary: | summary |