Phaser Lipoplasty System (DUR-01), Phaser Disposable Kit (DIS-01), Phaser Waste Collection Kit (WAS-01), Phaser Cannulae

FDA 510(k) K092066 · Andrew Technologies, LLC

Substantially Equivalent

510(k) numberK092066

Submission

Device name
Phaser Lipoplasty System (DUR-01), Phaser Disposable Kit (DIS-01), Phaser Waste Collection Kit (WAS-01), Phaser Cannulae
Applicant
Andrew Technologies, LLC
Washington, DC, US
Received
July 8, 2009
Decision date
April 12, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QPB – System, Suction, Lipoplasty For Removal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5040
Specialty
General, Plastic Surgery

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

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More from Black & Black Surgical, Inc.

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Questions and answers

When was Phaser Lipoplasty System (DUR-01), Phaser Disposable Kit (DIS-01), Phaser Waste Collection Kit (WAS-01), Phaser Cannulae cleared by the FDA?

Phaser Lipoplasty System (DUR-01), Phaser Disposable Kit (DIS-01), Phaser Waste Collection Kit (WAS-01), Phaser Cannulae (K092066) received a 510(k) decision of Substantially Equivalent on April 12, 2010, 278 days after the submission was received.

What is the product code of K092066?

The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.