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, Black & Black Surgical, Inc. and Byron Medical.

59
Total
59
Cleared
154d
Avg days
1998
Since
Growing category - 8 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 176d recently vs 150d historically

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

59 devices
1–24 of 59
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
Cleared Aug 17, 2012
MICROAIRE SURGICAL INSTRUMENTS LLC
K113128
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 298d

About Product Code QPB - Regulatory Context

510(k) Submission Activity

59 total 510(k) submissions under product code QPB since 1998, with 59 receiving FDA clearance (average review time: 154 days).

Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 3 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 176 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 →