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., Cutera, Inc. and BTL Industries, Inc..

81
Total
81
Cleared
194d
Avg days
2012
Since
Growing category - 17 submissions in the last 2 years vs 12 in the prior period
Review times increasing: avg 234d recently vs 184d historically

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

81 devices
1–24 of 81
Cleared Oct 13, 2026
TECAR Therapy Device (TC2000, TC2001)
K252288
Shenzhen Dongdixin Technology Co., Ltd.
General & Plastic Surgery · 447d
Cleared Sep 22, 2026
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
K243223
Bh Group Us, LLC
General & Plastic Surgery · 715d
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

About Product Code PBX - Regulatory Context

510(k) Submission Activity

81 total 510(k) submissions under product code PBX since 2012, with 81 receiving FDA clearance (average review time: 194 days).

Submission volume has increased in recent years - 17 submissions in the last 24 months compared to 12 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PBX Product Code

Recent submissions under PBX have taken an average of 234 days to reach a decision - up from 184 days historically. Manufacturers should account for longer review timelines in current project planning.

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