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
79 devices
49–72 of 79
Cleared Oct 29, 2019
EmFace Device
K191855
Inmode MD , Ltd.
General & Plastic Surgery · 111d
Cleared Jun 25, 2019
Venus Bliss
K190743
Venus Concept USA, Inc.
General & Plastic Surgery · 95d
Cleared Jun 20, 2019
EmBody System
K183450
Inmode MD , Ltd.
General & Plastic Surgery · 190d
Cleared Mar 29, 2019
BTL-084
K190023
BTL Industries, Inc.
General & Plastic Surgery · 84d
Cleared Feb 22, 2019
Doctor Tecar
K183693
Mectronic Medicale S.R.L.
General & Plastic Surgery · 53d
Cleared Feb 01, 2019
Family of Venus RF Systems - Heal
K182094
Venus Concept USA, Inc.
General & Plastic Surgery · 182d
Cleared Jan 29, 2019
T-PLUS
K181893
Wintecare SA
General & Plastic Surgery · 200d
Cleared Sep 10, 2018
Human Tecar HCR 1002
K181211
Unibell S.R.L
General & Plastic Surgery · 126d
Cleared Jul 24, 2018
RF-Relief
K181095
El Global Trade, Ltd.
General & Plastic Surgery · 89d
Cleared Jun 06, 2018
truSculpt RF Device
K180709
Cutera, Inc.
General & Plastic Surgery · 79d
Cleared Dec 08, 2017
InMode PLUS System
K172302
Inmode MD , Ltd.
General & Plastic Surgery · 130d
Cleared Oct 20, 2017
Ultimate Contour, Ultimate Contour Mini
K171052
CAO Group, Inc.
General & Plastic Surgery · 193d
Cleared Sep 18, 2017
Winback Back 3SE
K162828
Winback USA Corp
General & Plastic Surgery · 346d
Cleared Aug 02, 2017
truSculpt
K172004
Cutera, Inc.
General & Plastic Surgery · 30d
Cleared Jul 14, 2017
sensiFirm
K170637
El Global Trade, Ltd.
General & Plastic Surgery · 134d
Cleared Jan 12, 2017
Exilis XP II
K163176
BTL Industries, Inc.
General & Plastic Surgery · 59d
Cleared Dec 09, 2016
truSculpt
K162512
Cutera, Inc.
General & Plastic Surgery · 92d
Cleared Oct 03, 2016
Indiba Diathermia Radiofrequency Device - Activ
K161458
Indiba USA, Inc.
General & Plastic Surgery · 130d
Cleared Sep 13, 2016
TR-100
K161551
BTL Industries, Inc.
General & Plastic Surgery · 102d
Cleared Sep 12, 2016
Profound System
K161043
Syneron Candela Corporation
General & Plastic Surgery · 152d
Cleared Aug 19, 2016
InMode System MiniFX Handpiece
K160329
Inmode MD , Ltd.
General & Plastic Surgery · 196d
Cleared Aug 01, 2016
EndyMed Contour Handpiece
K161199
Endymed Medical, Ltd.
General & Plastic Surgery · 95d
Cleared Jul 12, 2016
InMode Plus System
K153568
Inmode MD , Ltd.
General & Plastic Surgery · 211d
Cleared Nov 19, 2015
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
K151296
Bios S.R.L.
General & Plastic Surgery · 188d