510(k) K053451
K053451 is an FDA 510(k) premarket notification submitted by Moeller Medical GmbH & Co. KG for the device "LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);". The FDA issued a decision of Substantially Equivalent on Aug 25, 2006. 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
- Aug 25, 2006
- Date Received
- Dec 12, 2005
- Clearance Type
- Traditional
- 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