Data / Medical devices / Italy / Lipogems International S.P.A.
Lipogems International S.P.A.: FDA-registered device maker in Milan Milano, Italy, 3 510(k) clearances
Lipogems International S.P.A. is registered with the FDA (registration 3010742783) in Milan Milano, Italy. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 18, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010742783
- Address
- Viale Bianca Maria 24, Milan Milano, Italy, 20129
- Owner or operator
- Lipogems International S.p.A. (10049059)
- Roles
- Specification developer
- First device listed
- April 8, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | 2 | Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2017 | K171135 | Lipogems System | MUU | Substantially Equivalent | Lipogems International Spa | accessdata.fda.gov |
| November 4, 2016 | K161636 | Lipogems System | MUU | Substantially Equivalent | Lipogems International Spa | accessdata.fda.gov |
| December 22, 2014 | K142682 | The Lipogems System | MUU | Substantially Equivalent | Lipogems International Spa | accessdata.fda.gov |
Compare with other makers
- All makers of System, Suction, Lipoplasty
- All makers of Lipoaspirate Washing System For Aesthetic Body Contouring
Updated May 18, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.