510(k) K190555
K190555 is an FDA 510(k) premarket notification submitted by Solta Medical for the device "PowerX Lipo System". The FDA issued a decision of Substantially Equivalent on May 1, 2019. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Solta Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2019
- Date Received
- March 5, 2019
- 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
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring