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
78 devices
25–48 of 78
Cleared Feb 17, 2023
Doctor Tecar Plus, Doctor Tecar Smart
K221043
Mectronic Medicale S.R.L.
General & Plastic Surgery · 315d
Cleared Nov 17, 2022
C.C. LIFE 21
K213295
21 Equipment S.R.L.
General & Plastic Surgery · 412d
Cleared Nov 01, 2022
Back 3 COLOR
K214090
Swims America Corp
General & Plastic Surgery · 308d
Cleared Sep 26, 2022
Palm NRG cellulite body device (model: Palm NRG body device)
K214015
Heat IN A Click, LLC
General & Plastic Surgery · 278d
Cleared Aug 25, 2022
Apollo Duet (Model : APD-4000)
K212253
Weero Co.
General & Plastic Surgery · 402d
Cleared Jun 06, 2022
Diacare 7000
K211207
Globus Sport and Health Technologies, LLC
General & Plastic Surgery · 410d
Cleared Apr 27, 2022
Venus BlissMAX
K220592
Venus Concept USA, Inc.
General & Plastic Surgery · 57d
Cleared Jan 12, 2022
Venus BlissMAX
K213308
Venus Concept USA, Inc.
Physical Medicine · 100d
Cleared Oct 15, 2021
Deka Tiac II
K211091
El.En Electronic Engineering Spa
General & Plastic Surgery · 186d
Cleared Oct 14, 2021
Family of Venus RF Systems - Venus Freedom
K211461
Venus Concept USA, Inc.
General & Plastic Surgery · 156d
Cleared Jul 30, 2021
Sectum
K202780
Neauvia North America
General & Plastic Surgery · 311d
Cleared Jul 20, 2021
RF Thermal System
K210129
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 182d
Cleared Jul 19, 2021
Evolve System with the T3 Applicator
K210877
Inmode , Ltd.
General & Plastic Surgery · 117d
Cleared Apr 21, 2021
NuEra Tight RF, NuEra Tight RF Plus
K210867
Bios S.R.L.
General & Plastic Surgery · 29d
Cleared Dec 09, 2020
V30 system, V20 system, V10 system, V-VR Hand piece
K202247
Viora , Ltd.
General & Plastic Surgery · 121d
Cleared Nov 03, 2020
Palm NRG cellulite and muscle toning body device
K191940
Heat IN A Click
General & Plastic Surgery · 473d
Cleared Oct 28, 2020
Ultimate Contour, Ultimate Contour Mini
K201475
CAO Group, Inc.
General & Plastic Surgery · 147d
Cleared Aug 11, 2020
NuEra Tight, NuEra Tight EMS
K200359
Bios S.R.L.
General & Plastic Surgery · 180d
Cleared Jul 15, 2020
V30 System, V20 System, V10 System, V-FR Handpiece
K201064
Viora , Ltd.
General & Plastic Surgery · 85d
Cleared May 21, 2020
V30 system, V20 system, V10 system, V-FC Handpiece
K200468
Viora , Ltd.
General & Plastic Surgery · 85d
Cleared Mar 25, 2020
TempSure System
K200241
Cynosure, LLC
General & Plastic Surgery · 54d
Cleared Feb 11, 2020
CAPENERGY - C100, C200, C300, C400, C50
K191202
Capenergy Medical S.L.
General & Plastic Surgery · 281d
Cleared Dec 03, 2019
Deka Tiac 1
K183371
El..En. Electroic Engineering Spa
General & Plastic Surgery · 362d
Cleared Oct 29, 2019
EmFace Device
K191855
Inmode MD , Ltd.
General & Plastic Surgery · 111d