PBX · Class II · 21 CFR 878.4400

FDA Product Code PBX: Massager, Vacuum, Radio Frequency Induced Heat

Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.

Leading manufacturers include Venus Concept USA, Inc., Bios S.R.L. and Swims America Corp.

78
Total
78
Cleared
183d
Avg days
2012
Since
Growing category - 16 submissions in the last 2 years vs 13 in the prior period
Consistent review times: 182d avg (recent)

FDA 510(k) Cleared Massager, Vacuum, Radio Frequency Induced Heat Devices (Product Code PBX)

78 devices
1–24 of 78
Cleared Apr 02, 2026
SPECCHIO
K260647
El.En S.P.A.
General & Plastic Surgery · 34d
Cleared Mar 13, 2026
Apollo Quattro (APQ-10M)
K253261
Weero Co., Ltd.
General & Plastic Surgery · 165d
Cleared Mar 09, 2026
NeoSculpt Plus
K252888
S&M Medical Co., Ltd.
General & Plastic Surgery · 180d
Cleared Sep 10, 2025
OptiLUV Device
K250734
Pollogen, Ltd.
General & Plastic Surgery · 183d
Cleared Aug 14, 2025
WinForth (LM-E470KA)
K250916
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 140d
Cleared May 28, 2025
Zionic Pro Max (Radiofrequency)
K243716
Termosalud S.L.
General & Plastic Surgery · 177d
Cleared Apr 16, 2025
HEBE (NP0000763)
K241733
Novasonix Technology S.L.
General & Plastic Surgery · 303d
Cleared Apr 15, 2025
Préime DermaFacial Collagen+
K243055
EMA Aesthetics , Ltd.
General & Plastic Surgery · 200d
Cleared Feb 27, 2025
XOD Diathermia Radiofrequency Device
K242175
Xod, Inc.
General & Plastic Surgery · 218d
Cleared Jan 24, 2025
Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY )
K241107
Indiba S. A. U.
General & Plastic Surgery · 277d
Cleared Dec 26, 2024
FISIOWARM 7.0
K232966
Golden Star Srl
General & Plastic Surgery · 462d
Cleared Nov 21, 2024
MIRARI® Cold Plasma System ( GV-M2-01)
K242553
General Vibronics, Inc.
General & Plastic Surgery · 86d
Cleared Nov 20, 2024
INDIBA COMPACT devices
K243164
Indiba S. A. U.
General & Plastic Surgery · 51d
Cleared Nov 14, 2024
DEFINE System (AG612444A)
K242598
Inmode , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 09, 2024
eMVFit (MVF-10M)
K240991
Weero Co., Ltd.
General & Plastic Surgery · 181d
Cleared Jul 15, 2024
RFG-01
K240178
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 174d
Cleared Oct 30, 2023
NuEra Tight RF Model OptiStream
K230755
Bios S.R.L.
General & Plastic Surgery · 227d
Cleared Jul 19, 2023
BACK 3
K230037
Swims America Corp
General & Plastic Surgery · 194d
Cleared Jun 08, 2023
Zionic Aesthetic
K230659
Termosalud
General & Plastic Surgery · 91d
Cleared May 25, 2023
ThermoTK
K213256
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 602d
Cleared May 02, 2023
NuEra Tight RF Model APMD145.M70-US
K223907
Bios S.R.L.
General & Plastic Surgery · 125d
Cleared Apr 13, 2023
Symmed Elite Aesthetic
K230412
Termosalud
General & Plastic Surgery · 57d
Cleared Mar 28, 2023
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
K222260
Capenergy Medical S.L.
General & Plastic Surgery · 243d
Cleared Mar 01, 2023
RSHOCK
K220014
Swims America Corp
General & Plastic Surgery · 420d

About Product Code PBX - Regulatory Context

510(k) Submission Activity

78 total 510(k) submissions under product code PBX since 2012, with 78 receiving FDA clearance (average review time: 183 days).

Submission volume has increased in recent years - 16 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PBX Product Code

FDA review times for PBX submissions have been consistent, averaging 182 days recently vs 184 days historically.

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