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 Bios S.R.L., Inmode MD , Ltd. and Venus Concept USA, Inc..

79
Total
79
Cleared
184d
Avg days
2012
Since
Growing category - 16 submissions in the last 2 years vs 13 in the prior period
Consistent review times: 188d avg (recent)

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

79 devices
1–24 of 79
Cleared Jul 10, 2026
Capenergy C Equipments RF C200 and C400 Drakarian
K253480
Capenergy Medical S.L.
General & Plastic Surgery · 269d
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

About Product Code PBX - Regulatory Context

510(k) Submission Activity

79 total 510(k) submissions under product code PBX since 2012, with 79 receiving FDA clearance (average review time: 184 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 188 days recently vs 184 days historically.

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