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, Solta Medical and Apyx Medical Corporation.

57
Total
57
Cleared
151d
Avg days
1998
Since
Growing category - 8 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 282d recently vs 130d historically

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

57 devices
1–24 of 57
Cleared May 08, 2026
AYON Body Contouring System™ (AYON SYSTEM)
K253396
Apyx Medical Corporation
General & Plastic Surgery · 220d
Cleared Apr 03, 2026
LSSA (NP-200)
K252495
Newpong Co., Ltd.
General & Plastic Surgery · 238d
Cleared May 12, 2025
AYON Body Contouring System (AYON SYSTEM)
K244050
Apyx Medical Corporation
General & Plastic Surgery · 132d
Cleared Apr 25, 2025
PAL 7020 Console
K244026
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 116d
Cleared Dec 30, 2024
PAL Aspiration System
K242804
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 104d
Cleared Nov 27, 2024
AirSculpt Body Contouring System (AIRS-1-SYS)
K241835
Cellmyx
General & Plastic Surgery · 155d
Cleared Sep 13, 2024
Vitruvian Liposaber
K240188
Black & Black Surgical, Inc.
General & Plastic Surgery · 233d
Cleared Aug 07, 2024
Liposaver
K212969
Lhbiomed Co., Ltd.
General & Plastic Surgery · 1056d
Cleared Oct 14, 2022
PAL Infiltration System
K220318
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 253d
Cleared Jun 10, 2022
PAL System
K212024
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 346d
Cleared May 14, 2020
PAL Single-Use Cannulas
K192694
Microaire Surgical Instruments
General & Plastic Surgery · 231d
Cleared Apr 22, 2020
Dermapose Access
K200168
Puregraft, LLC
General & Plastic Surgery · 90d
Cleared May 01, 2019
VASERlipo System
K190551
Solta Medical
General & Plastic Surgery · 57d
Cleared May 01, 2019
PowerX Lipo System
K190555
Solta Medical
General & Plastic Surgery · 57d

About Product Code QPB - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code QPB since 1998, with 57 receiving FDA clearance (average review time: 151 days).

Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QPB Product Code

Recent submissions under QPB have taken an average of 282 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 →