FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K213295 |
21 Equipment S.R.L. |
C.C. LIFE 21 |
11/17/2022 |
K151296 |
BIOS S.R.L. |
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) |
11/19/2015 |
K223907 |
BIOS s.r.l. |
NuEra Tight RF Model APMD145.M70-US |
05/02/2023 |
K210867 |
BIOS s.r.l. |
NuEra Tight RF, NuEra Tight RF Plus |
04/21/2021 |
K200359 |
Bios s.r.l. |
NuEra Tight, NuEra Tight EMS |
08/11/2020 |
K143040 |
BTL INDUSTRIES INC |
Exilis XP |
01/15/2015 |
K190023 |
BTL Industries, Inc. |
BTL-084 |
03/29/2019 |
K163176 |
BTL Industries, Inc. |
Exilis XP II |
01/12/2017 |
K161551 |
BTL INDUSTRIES, INC. |
TR-100 |
09/13/2016 |
K150720 |
BTL Industries, Inc. |
XP3000 |
09/16/2015 |
K171052 |
CAO Group, Inc. |
Ultimate Contour, Ultimate Contour Mini |
10/20/2017 |
K201475 |
CAO Group, Inc. |
Ultimate Contour, Ultimate Contour Mini |
10/28/2020 |
K222260 |
Capenergy Medical S.L. |
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 |
03/28/2023 |
K191202 |
Capenergy Medical SL |
CAPENERGY - C100, C200, C300, C400, C50 |
02/11/2020 |
K122389 |
CUTERA, INC. |
TRUSCULPT |
11/02/2012 |
K133739 |
CUTERA, INC. |
TRUSCULPT |
09/05/2014 |
K162512 |
CUTERA, INC. |
truSculpt |
12/09/2016 |
K172004 |
Cutera, Inc. |
truSculpt |
08/02/2017 |
K180709 |
Cutera, Inc. |
truSculpt RF Device; truSculpt; truSculpt 3D |
06/06/2018 |
K200241 |
Cynosure LLC |
TempSure System |
03/25/2020 |
K181095 |
EL Global Trade Ltd |
RF-Relief |
07/24/2018 |
K170637 |
EL Global Trade Ltd |
sensiFirm |
07/14/2017 |
K183371 |
El..En. Electroic Engineering SpA |
Deka Tiac 1 |
12/03/2019 |
K211091 |
EL.EN Electronic Engineering Spa |
Deka Tiac II |
10/15/2021 |
K132949 |
ELLMAN INTERNATIONAL, INC. |
PELLEFIRM |
02/20/2014 |
K161199 |
ENDYMED MEDICAL LTD. |
EndyMed Contour Handpiece |
08/01/2016 |
K211207 |
Globus Sport and Health Technologies LLC |
Diacare 7000 |
06/06/2022 |
K191940 |
Heat In A Click |
Palm NRG cellulite and muscle toning body device |
11/03/2020 |
K214015 |
Heat In A Click LLC. |
Palm NRG cellulite body device (model: Palm NRG body device) |
09/26/2022 |
K161458 |
Indiba USA Inc. |
Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care |
10/03/2016 |
K210877 |
InMode Ltd. |
Evolve System with the T3 Applicator |
07/19/2021 |
K183450 |
InMode MD Ltd. |
EmBody System |
06/20/2019 |
K191855 |
InMode MD Ltd. |
EmFace Device |
10/29/2019 |
K172302 |
InMode MD Ltd. |
InMode PLUS System |
12/08/2017 |
K153568 |
InMode MD Ltd. |
InMode Plus System |
07/12/2016 |
K160329 |
InMode MD Ltd. |
InMode System MiniFX Handpiece |
08/19/2016 |
K210129 |
Luvo Medical Technologies, Inc |
RF Thermal System |
07/20/2021 |
K183693 |
Mectronic Medicale S.r.l. |
Doctor Tecar |
02/22/2019 |
K221043 |
Mectronic Medicale S.r.l. |
Doctor Tecar Plus, Doctor Tecar Smart |
02/17/2023 |
K202780 |
Neauvia North America |
Sectum |
07/30/2021 |
K230037 |
SWIMS America Corp |
BACK 3 |
07/19/2023 |
K214090 |
SWIMS America Corp |
Back 3 COLOR |
11/01/2022 |
K220014 |
SWIMS America Corp |
RSHOCK |
03/01/2023 |
K161043 |
SYNERON CANDELA CORPORATION |
Profound System |
09/12/2016 |
K230412 |
TermoSalud |
Symmed Elite Aesthetic |
04/13/2023 |
K230659 |
TermoSalud |
Zionic Aesthetic |
06/08/2023 |
K181211 |
UNIBELL S.r.l |
Human Tecar HCR 1002 |
09/10/2018 |
K143554 |
Venus Concept Ltd. |
Venus Legacy CX |
08/04/2015 |
K182094 |
Venus Concept USA Inc. |
Family of Venus RF Systems - Heal |
02/01/2019 |
K211461 |
Venus Concept USA Inc. |
Family of Venus RF Systems - Venus Freedom |
10/14/2021 |
K190743 |
Venus Concept USA Inc. |
Venus Bliss |
06/25/2019 |
K213308 |
Venus Concept USA Inc. |
Venus BlissMAX |
01/12/2022 |
K220592 |
Venus Concept USA Inc. |
Venus BlissMAX |
04/27/2022 |
K150035 |
VIORA LTD. |
V10 system |
05/01/2015 |
K200468 |
Viora Ltd. |
V30 system, V20 system, V10 system, V-FC Handpiece |
05/21/2020 |
K201064 |
Viora Ltd. |
V30 System, V20 System, V10 System, V-FR Handpiece |
07/15/2020 |
K202247 |
Viora Ltd. |
V30 system, V20 system, V10 system, V-VR Hand piece |
12/09/2020 |
K212253 |
Weero Co. |
Apollo Duet (Model : APD-4000) |
08/25/2022 |
K162828 |
WINBACK USA CORP |
Winback Back 3SE |
09/18/2017 |
K181893 |
Wintecare SA |
T-PLUS |
01/29/2019 |
K213256 |
Zimmer MedizinSysteme GmbH |
ThermoTK |
05/25/2023 |