510(k) K101413
K101413 is an FDA 510(k) premarket notification submitted by Euromi S.A for the device "EUROMI EVA SP6". The FDA issued a decision of Substantially Equivalent on Dec 16, 2010. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Euromi S.A has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 2010
- Date Received
- May 20, 2010
- 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