The following data is part of a premarket notification filed by Lipogems International Spa with the FDA for Lipogems System.
| Device ID | K161636 |
| 510k Number | K161636 |
| Device Name: | Lipogems System |
| Classification | System, Suction, Lipoplasty |
| Applicant | Lipogems International SpA viale Bianca Maria 24 Milano, IT 20129 |
| Contact | Carlo Russo |
| Correspondent | Scott Bruder Bruder Consulting International, LLC 268 Glen Place Franklin Lakes, NJ 07417 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-14 |
| Decision Date | 2016-11-04 |
| Summary: | summary |