510(k) K171286
K171286 is an FDA 510(k) premarket notification submitted by Microaire Surgical Instruments, LLC for the device "PAL Multi-Use Cannulas and PAL Manual Wand". The FDA issued a decision of Substantially Equivalent on October 13, 2017. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Microaire Surgical Instruments, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2017
- Date Received
- May 1, 2017
- 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