510(k) K072793
K072793 is an FDA 510(k) premarket notification submitted by Moeller Medical GmbH & Co. KG for the device "LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688". The FDA issued a decision of Substantially Equivalent on Mar 4, 2008. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Moeller Medical GmbH & Co. KG has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 4, 2008
- Date Received
- Oct 1, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Suction, Lipoplasty For Removal
- Device Class
- Class II
- Regulation Number
- 878.5040
- Review Panel
- SU
- Submission Type
- 510(k)
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring