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, Apyx Medical Corporation and Byron Medical.

60
Total
60
Cleared
155d
Avg days
1998
Since
Growing category - 9 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 185d recently vs 150d historically

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

60 devices
1–24 of 60
Cleared Sep 05, 2026
LipoSurg ARTIST
K254135
NOUVAG AG
General & Plastic Surgery · 257d
Cleared Aug 21, 2026
AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors
K261710
Apyx Medical Corporation
General & Plastic Surgery · 91d
Cleared Jun 08, 2026
Lipocosm Harmonic System
K251944
Lipocosm, LLC
General & Plastic Surgery · 349d
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
Cleared Oct 13, 2017
PAL Multi-Use Cannulas and PAL Manual Wand
K171286
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 165d
Cleared Jun 22, 2017
VITRUVIAN INFILTRATION PUMP
K170629
Black & Black Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Mar 24, 2017
Basic, Dominant Flex
K170329
Modela AG
General & Plastic Surgery · 50d
Cleared Jul 26, 2016
VITRUVIAN ULTIMATE ASPIRATOR
K161722
Black & Black Surgical, Inc.
General & Plastic Surgery · 34d
Cleared Apr 21, 2015
Basic, Dominant Flex, KV-6
K150134
Medela AG
General & Plastic Surgery · 90d
Cleared Jul 30, 2014
SUCTION LIPOPLASTY ACCESSORIES
K132353
Inex
General & Plastic Surgery · 366d
Cleared Dec 13, 2012
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
K121218
Andrew Technologies, LLC
General & Plastic Surgery · 234d

About Product Code QPB - Regulatory Context

510(k) Submission Activity

60 total 510(k) submissions under product code QPB since 1998, with 60 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 2 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 185 days to reach a decision - up from 150 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 →