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79 FDA 510(k) clearances · Product code

174 daysmedian time to decision
362 days90th percentile
79clearances measured

FDA profile

Official device name
Massager, Vacuum, Radio Frequency Induced Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
FDA 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.
Adverse events (MAUDE)
2013: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Capenergy C Equipments RF C200 and C400 Drakarian (K253480)Capenergy Medical S.L.2026-07-10
SPECCHIO (K260647)El.En S.P.A.2026-04-02
Apollo Quattro (APQ-10M) (K253261)Weero Co., Ltd.2026-03-13
NeoSculpt Plus (K252888)S&M Medical Co., Ltd.2026-03-09
OptiLUV Device (K250734)Pollogen, Ltd.2025-09-10
WinForth (LM-E470KA) (K250916)Shenzhen Leaflife Technology Co., Ltd.2025-08-14
Zionic Pro Max (Radiofrequency) (K243716)Termosalud S.L.2025-05-28
HEBE (NP0000763) (K241733)Novasonix Technology S.L.2025-04-16
Préime DermaFacial Collagen+ (K243055)EMA Aesthetics , Ltd.2025-04-15
XOD Diathermia Radiofrequency Device (K242175)Xod, Inc.2025-02-27
Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) (K241107)Indiba S. A. U.2025-01-24
FISIOWARM 7.0 (K232966)Golden Star Srl2024-12-26
MIRARI® Cold Plasma System ( GV-M2-01) (K242553)General Vibronics, Inc.2024-11-21
INDIBA COMPACT devices (K243164)Indiba S. A. U.2024-11-20
DEFINE System (AG612444A) (K242598)InMode , Ltd.2024-11-14
eMVFit (MVF-10M) (K240991)Weero Co., Ltd.2024-10-09
RFG-01 (K240178)Zimmer Medizinsysteme GmbH2024-07-15
NuEra Tight RF Model OptiStream (K230755)Bios S.R.L.2023-10-30
BACK 3 (K230037)Swims America Corp2023-07-19
Zionic Aesthetic (K230659)Termosalud2023-06-08
ThermoTK (K213256)Zimmer Medizinsysteme GmbH2023-05-25
NuEra Tight RF Model APMD145.M70-US (K223907)Bios S.R.L.2023-05-02
Symmed Elite Aesthetic (K230412)Termosalud2023-04-13
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (K222260)Capenergy Medical S.L.2023-03-28
RSHOCK (K220014)Swims America Corp2023-03-01
Doctor Tecar Plus, Doctor Tecar Smart (K221043)Mectronic Medicale S.R.L.2023-02-17
C.C. LIFE 21 (K213295)21 Equipment S.R.L.2022-11-17
Back 3 COLOR (K214090)Swims America Corp2022-11-01
Palm NRG cellulite body device (model: Palm NRG body device) (K214015)Heat IN A Click, LLC2022-09-26
Apollo Duet (Model : APD-4000) (K212253)Weero Co.2022-08-25
Diacare 7000 (K211207)Globus Sport and Health Technologies, LLC2022-06-06
Venus BlissMAX (K220592)Venus Concept USA, Inc.2022-04-27
Venus BlissMAX (K213308)Venus Concept USA, Inc.2022-01-12
Deka Tiac II (K211091)El.En Electronic Engineering Spa2021-10-15
Family of Venus RF Systems - Venus Freedom (K211461)Venus Concept USA, Inc.2021-10-14
Sectum (K202780)Neauvia North America2021-07-30
RF Thermal System (K210129)Luvo Medical Technologies, Inc.2021-07-20
Evolve System with the T3 Applicator (K210877)InMode , Ltd.2021-07-19
NuEra Tight RF, NuEra Tight RF Plus (K210867)Bios S.R.L.2021-04-21
V30 system, V20 system, V10 system, V-VR Hand piece (K202247)Viora , Ltd.2020-12-09
Palm NRG cellulite and muscle toning body device (K191940)Heat IN A Click2020-11-03
Ultimate Contour, Ultimate Contour Mini (K201475)CAO Group, Inc.2020-10-28
NuEra Tight, NuEra Tight EMS (K200359)Bios S.R.L.2020-08-11
V30 System, V20 System, V10 System, V-FR Handpiece (K201064)Viora , Ltd.2020-07-15
V30 system, V20 system, V10 system, V-FC Handpiece (K200468)Viora , Ltd.2020-05-21
TempSure System (K200241)Cynosure, LLC2020-03-25
CAPENERGY - C100, C200, C300, C400, C50 (K191202)Capenergy Medical S.L.2020-02-11
Deka Tiac 1 (K183371)El..En. Electroic Engineering Spa2019-12-03
EmFace Device (K191855)Inmode MD , Ltd.2019-10-29
Venus Bliss (K190743)Venus Concept USA, Inc.2019-06-25
EmBody System (K183450)Inmode MD , Ltd.2019-06-20
BTL-084 (K190023)BTL Industries, Inc.2019-03-29
Doctor Tecar (K183693)Mectronic Medicale S.R.L.2019-02-22
Family of Venus RF Systems - Heal (K182094)Venus Concept USA, Inc.2019-02-01
T-PLUS (K181893)Wintecare SA2019-01-29
Human Tecar HCR 1002 (K181211)Unibell S.R.L2018-09-10
RF-Relief (K181095)El Global Trade, Ltd.2018-07-24
truSculpt RF Device; truSculpt; truSculpt 3D (K180709)Cutera, Inc.2018-06-06
InMode PLUS System (K172302)Inmode MD , Ltd.2017-12-08
Ultimate Contour, Ultimate Contour Mini (K171052)CAO Group, Inc.2017-10-20
Winback Back 3SE (K162828)Winback USA Corp2017-09-18
truSculpt (K172004)Cutera, Inc.2017-08-02
sensiFirm (K170637)El Global Trade, Ltd.2017-07-14
Exilis XP II (K163176)BTL Industries, Inc.2017-01-12
truSculpt (K162512)Cutera, Inc.2016-12-09
Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care (K161458)Indiba USA, Inc.2016-10-03
TR-100 (K161551)BTL Industries, Inc.2016-09-13
Profound System (K161043)Syneron Candela Corporation2016-09-12
InMode System MiniFX Handpiece (K160329)Inmode MD , Ltd.2016-08-19
EndyMed Contour Handpiece (K161199)Endymed Medical, Ltd.2016-08-01
InMode Plus System (K153568)Inmode MD , Ltd.2016-07-12
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) (K151296)Bios S.R.L.2015-11-19
XP3000 (K150720)BTL Industries, Inc.2015-09-16
Venus Legacy CX (K143554)Venus Concept , Ltd.2015-08-04
V10 system (K150035)Viora , Ltd.2015-05-01
Exilis XP (K143040)BTL Industries, Inc.2015-01-15
TRUSCULPT (K133739)Cutera, Inc.2014-09-05
PELLEFIRM (K132949)Ellman International, Inc.2014-02-20
TRUSCULPT (K122389)Cutera, Inc.2012-11-02

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