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510(k) K092066

PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE by Andrew Technologies, LLC — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2010
Date Received
July 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

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

Other clearances by Andrew Technologies, LLC

  • K130152 — HYDRASOLVE LIPOPLASTY SYSTEM (April 18, 2013)
  • K121218 — HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH (December 13, 2012)

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