510(k) K092066
K092066 is an FDA 510(k) premarket notification submitted by Andrew Technologies, LLC for the device "PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE". The FDA issued a decision of Substantially Equivalent on Apr 12, 2010. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Andrew Technologies, LLC has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 12, 2010
- Date Received
- Jul 8, 2009
- 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