510(k) K252495
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2026
- Date Received
- August 8, 2025
- 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
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring