QKL — Lipoaspirate Washing System For Aesthetic Body Contouring Class II

FDA Device Classification

FDA product code QKL covers "Lipoaspirate Washing System For Aesthetic Body Contouring", a Class II medical device regulated under 21 CFR 878.5040. Submissions are reviewed by the General, Plastic Surgery panel.

Classification Details

Product Code
QKL
Device Class
Class II
Regulation Number
878.5040
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation