Product Code: PBX FDA class 2 21 CFR 878.4400

Massager, Vacuum, Radio Frequency Induced Heat

General, Plastic Surgery

The Massager, Vacuum, Radio Frequency Induced Heat is a combination device that uses vacuum massage and radiofrequency-induced heat to generate warmth in body tissues for minor relief of aches and pain, and to provide a temporary reduction in the appearance of cellulite. It falls under the General and Plastic Surgery medical specialty and is classified as a Class 2 device under regulation 878.4400, requiring 510(k) premarket notification. The device is eligible for third-party review. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: PBX
Device Class: FDA class 2
Regulation Number: 878.4400
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 78 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260647	SPECCHIO	Apr 02, 2026	Substantially Equivalent	El.En S.P.A.
K253261	Apollo Quattro (APQ-10M)	Mar 13, 2026	Substantially Equivalent	Weero Co., Ltd.
K252888	NeoSculpt Plus	Mar 09, 2026	Substantially Equivalent	S&M Medical Co., Ltd.
K250734	OptiLUV Device	Sep 10, 2025	Substantially Equivalent	Pollogen, Ltd.
K250916	WinForth (LM-E470KA)	Aug 14, 2025	Substantially Equivalent	Shenzhen Leaflife Technology Co., Ltd.
K243716	Zionic Pro Max (Radiofrequency)	May 28, 2025	Substantially Equivalent	Termosalud S.L.
K241733	HEBE (NP0000763)	Apr 16, 2025	Substantially Equivalent	Novasonix Technology S.L.
K243055	Préime DermaFacial Collagen+	Apr 15, 2025	Substantially Equivalent	EMA Aesthetics , Ltd.
K242175	XOD Diathermia Radiofrequency Device	Feb 27, 2025	Substantially Equivalent	Xod, Inc.
K241107	Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)	Jan 24, 2025	Substantially Equivalent	Indiba S. A. U.
K232966	FISIOWARM 7.0	Dec 26, 2024	Substantially Equivalent	Golden Star Srl
K242553	MIRARI® Cold Plasma System ( GV-M2-01)	Nov 21, 2024	Substantially Equivalent	General Vibronics, Inc.
K243164	INDIBA COMPACT devices	Nov 20, 2024	Substantially Equivalent	Indiba S. A. U.
K242598	DEFINE System (AG612444A)	Nov 14, 2024	Substantially Equivalent	InMode , Ltd.
K240991	eMVFit (MVF-10M)	Oct 09, 2024	Substantially Equivalent	Weero Co., Ltd.
K240178	RFG-01	Jul 15, 2024	Substantially Equivalent	Zimmer Medizinsysteme GmbH
K230755	NuEra Tight RF Model OptiStream	Oct 30, 2023	Substantially Equivalent	Bios S.R.L.
K230037	BACK 3	Jul 19, 2023	Substantially Equivalent	Swims America Corp
K230659	Zionic Aesthetic	Jun 08, 2023	Substantially Equivalent	Termosalud
K213256	ThermoTK	May 25, 2023	Substantially Equivalent	Zimmer Medizinsysteme GmbH
K223907	NuEra Tight RF Model APMD145.M70-US	May 02, 2023	Substantially Equivalent	Bios S.R.L.
K230412	Symmed Elite Aesthetic	Apr 13, 2023	Substantially Equivalent	Termosalud
K222260	Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500	Mar 28, 2023	Substantially Equivalent	Capenergy Medical S.L.
K220014	RSHOCK	Mar 01, 2023	Substantially Equivalent	Swims America Corp
K221043	Doctor Tecar Plus, Doctor Tecar Smart	Feb 17, 2023	Substantially Equivalent	Mectronic Medicale S.R.L.
K213295	C.C. LIFE 21	Nov 17, 2022	Substantially Equivalent	21 Equipment S.R.L.
K214090	Back 3 COLOR	Nov 01, 2022	Substantially Equivalent	Swims America Corp
K214015	Palm NRG cellulite body device (model: Palm NRG body device)	Sep 26, 2022	Substantially Equivalent	Heat IN A Click, LLC
K212253	Apollo Duet (Model : APD-4000)	Aug 25, 2022	Substantially Equivalent	Weero Co.
K211207	Diacare 7000	Jun 06, 2022	Substantially Equivalent	Globus Sport and Health Technologies, LLC
K220592	Venus BlissMAX	Apr 27, 2022	Substantially Equivalent	Venus Concept USA, Inc.
K213308	Venus BlissMAX	Jan 12, 2022	Substantially Equivalent	Venus Concept USA, Inc.
K211091	Deka Tiac II	Oct 15, 2021	Substantially Equivalent	El.En Electronic Engineering Spa
K211461	Family of Venus RF Systems - Venus Freedom	Oct 14, 2021	Substantially Equivalent	Venus Concept USA, Inc.
K202780	Sectum	Jul 30, 2021	Substantially Equivalent	Neauvia North America
K210129	RF Thermal System	Jul 20, 2021	Substantially Equivalent	Luvo Medical Technologies, Inc.
K210877	Evolve System with the T3 Applicator	Jul 19, 2021	Substantially Equivalent	InMode , Ltd.
K210867	NuEra Tight RF, NuEra Tight RF Plus	Apr 21, 2021	Substantially Equivalent	Bios S.R.L.
K202247	V30 system, V20 system, V10 system, V-VR Hand piece	Dec 09, 2020	Substantially Equivalent	Viora , Ltd.
K191940	Palm NRG cellulite and muscle toning body device	Nov 03, 2020	Substantially Equivalent	Heat IN A Click
K201475	Ultimate Contour, Ultimate Contour Mini	Oct 28, 2020	Substantially Equivalent	CAO Group, Inc.
K200359	NuEra Tight, NuEra Tight EMS	Aug 11, 2020	Substantially Equivalent	Bios S.R.L.
K201064	V30 System, V20 System, V10 System, V-FR Handpiece	Jul 15, 2020	Substantially Equivalent	Viora , Ltd.
K200468	V30 system, V20 system, V10 system, V-FC Handpiece	May 21, 2020	Substantially Equivalent	Viora , Ltd.
K200241	TempSure System	Mar 25, 2020	Substantially Equivalent	Cynosure, LLC
K191202	CAPENERGY - C100, C200, C300, C400, C50	Feb 11, 2020	Substantially Equivalent	Capenergy Medical S.L.
K183371	Deka Tiac 1	Dec 03, 2019	Substantially Equivalent	El..En. Electroic Engineering Spa
K191855	EmFace Device	Oct 29, 2019	Substantially Equivalent	Inmode MD , Ltd.
K190743	Venus Bliss	Jun 25, 2019	Substantially Equivalent	Venus Concept USA, Inc.
K183450	EmBody System	Jun 20, 2019	Substantially Equivalent	Inmode MD , Ltd.
K190023	BTL-084	Mar 29, 2019	Substantially Equivalent	BTL Industries, Inc.
K183693	Doctor Tecar	Feb 22, 2019	Substantially Equivalent	Mectronic Medicale S.R.L.
K182094	Family of Venus RF Systems - Heal	Feb 01, 2019	Substantially Equivalent	Venus Concept USA, Inc.
K181893	T-PLUS	Jan 29, 2019	Substantially Equivalent	Wintecare SA
K181211	Human Tecar HCR 1002	Sep 10, 2018	Substantially Equivalent	Unibell S.R.L
K181095	RF-Relief	Jul 24, 2018	Substantially Equivalent	El Global Trade, Ltd.
K180709	truSculpt RF Device; truSculpt; truSculpt 3D	Jun 06, 2018	Substantially Equivalent	Cutera, Inc.
K172302	InMode PLUS System	Dec 08, 2017	Substantially Equivalent	Inmode MD , Ltd.
K171052	Ultimate Contour, Ultimate Contour Mini	Oct 20, 2017	Substantially Equivalent	CAO Group, Inc.
K162828	Winback Back 3SE	Sep 18, 2017	Substantially Equivalent	Winback USA Corp
K172004	truSculpt	Aug 02, 2017	Substantially Equivalent	Cutera, Inc.
K170637	sensiFirm	Jul 14, 2017	Substantially Equivalent	El Global Trade, Ltd.
K163176	Exilis XP II	Jan 12, 2017	Substantially Equivalent	BTL Industries, Inc.
K162512	truSculpt	Dec 09, 2016	Substantially Equivalent	Cutera, Inc.
K161458	Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care	Oct 03, 2016	Substantially Equivalent	Indiba USA, Inc.
K161551	TR-100	Sep 13, 2016	Substantially Equivalent	BTL Industries, Inc.
K161043	Profound System	Sep 12, 2016	Substantially Equivalent	Syneron Candela Corporation
K160329	InMode System MiniFX Handpiece	Aug 19, 2016	Substantially Equivalent	Inmode MD , Ltd.
K161199	EndyMed Contour Handpiece	Aug 01, 2016	Substantially Equivalent	Endymed Medical, Ltd.
K153568	InMode Plus System	Jul 12, 2016	Substantially Equivalent	Inmode MD , Ltd.
K151296	Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)	Nov 19, 2015	Substantially Equivalent	Bios S.R.L.
K150720	XP3000	Sep 16, 2015	Substantially Equivalent	BTL Industries, Inc.
K143554	Venus Legacy CX	Aug 04, 2015	Substantially Equivalent	Venus Concept , Ltd.
K150035	V10 system	May 01, 2015	Substantially Equivalent	Viora , Ltd.
K143040	Exilis XP	Jan 15, 2015	Substantially Equivalent	BTL Industries, Inc.
K133739	TRUSCULPT	Sep 05, 2014	Substantially Equivalent	Cutera, Inc.
K132949	PELLEFIRM	Feb 20, 2014	Substantially Equivalent	Ellman International, Inc.
K122389	TRUSCULPT	Nov 02, 2012	Substantially Equivalent	Cutera, Inc.