510(k) K161636
K161636 is an FDA 510(k) premarket notification submitted by Lipogems International Spa for the device "Lipogems System". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code MUU (System, Suction, Lipoplasty), a Class II device regulated under 21 CFR 878.5040. Lipogems International Spa has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2016
- Date Received
- June 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Suction, Lipoplasty
- Device Class
- Class II
- Regulation Number
- 878.5040
- Review Panel
- SU
- Submission Type
See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).