QPB · Class II · 21 CFR 878.5040

FDA Product Code QPB: System, Suction, Lipoplasty For Removal

A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring

Leading manufacturers include Microaire Surgical Instruments, LLC, Lhbiomed Co., Ltd. and Black & Black Surgical, Inc..

56
Total
56
Cleared
150d
Avg days
1998
Since
Growing category - 7 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 291d recently vs 130d historically

FDA 510(k) Cleared System, Suction, Lipoplasty For Removal Devices (Product Code QPB)

56 devices
1–24 of 56

About Product Code QPB - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code QPB since 1998, with 56 receiving FDA clearance (average review time: 150 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under QPB have taken an average of 291 days to reach a decision - up from 130 days historically. Manufacturers should account for longer review timelines in current project planning.

QPB devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →