Panels › General, Plastic Surgery › Product code PBX · Class 2
Massager, Vacuum, Radio Frequency Induced Heat
Regulation 878.4400
6510(k)s in 12 months (81 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PBX
| Company | 510(k)s | Recalls |
|---|---|---|
| Bios S.R.L. | 5 | 1 |
| Venus Concept , Ltd. | 6 | 0 |
| BTL Industries, Inc. | 5 | 0 |
| Cutera, Inc. | 5 | 0 |
| Inmode MD , Ltd. | 5 | 0 |
| Viora , Ltd. | 4 | 0 |
| Capenergy Medical S.L. | 3 | 0 |
| Swims America Corp | 3 | 0 |
| Weero Co. | 3 | 0 |
| CAO Group, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2019 | K191855 | EmFace Device Inmode MD , Ltd., IL | PBX |
| Jun 25, 2019 | K190743 | Venus Bliss Venus Concept USA, Inc. | PBX |
| Jun 20, 2019 | K183450 | EmBody System Inmode MD , Ltd., IL | PBX |
| Mar 29, 2019 | K190023 | BTL-084 BTL Industries, Inc. | PBX |
| Feb 22, 2019 | K183693 | Doctor Tecar Mectronic Medicale S.R.L., IT | PBX |
| Feb 1, 2019 | K182094 | Family of Venus RF Systems - Heal Venus Concept USA, Inc. | PBX |
| Jan 29, 2019 | K181893 | T-PLUS Wintecare SA, CH | PBX |
| Sep 10, 2018 | K181211 | Human Tecar HCR 1002 Unibell S.R.L, IT | PBX |
| Jul 24, 2018 | K181095 | RF-Relief El Global Trade, Ltd., IL | PBX |
| Jun 6, 2018 | K180709 | truSculpt RF Device; truSculpt; truSculpt 3D Cutera, Inc. | PBX |
| Dec 8, 2017 | K172302 | InMode PLUS System Inmode MD , Ltd., IL | PBX |
| Oct 20, 2017 | K171052 | Ultimate Contour, Ultimate Contour Mini CAO Group, Inc. | PBX |
| Sep 18, 2017 | K162828 | Winback Back 3SE Winback USA Corp | PBX |
| Aug 2, 2017 | K172004 | truSculpt Cutera, Inc. | PBX |
| Jul 14, 2017 | K170637 | sensiFirm El Global Trade, Ltd., IL | PBX |
| Jan 12, 2017 | K163176 | Exilis XP II BTL Industries, Inc. | PBX |
| Dec 9, 2016 | K162512 | truSculpt Cutera, Inc. | PBX |
| Oct 3, 2016 | K161458 | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care Indiba USA, Inc. | PBX |
| Sep 13, 2016 | K161551 | TR-100 BTL Industries, Inc. | PBX |
| Sep 12, 2016 | K161043 | Profound System Syneron Candela Corporation | PBX |
| Aug 19, 2016 | K160329 | InMode System MiniFX Handpiece Inmode MD , Ltd., IL | PBX |
| Aug 1, 2016 | K161199 | EndyMed Contour Handpiece Endymed Medical, Ltd., IL | PBX |
| Jul 12, 2016 | K153568 | InMode Plus System Inmode MD , Ltd., IL | PBX |
| Nov 19, 2015 | K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) Bios S.R.L., IT | PBX |
| Sep 16, 2015 | K150720 | XP3000 BTL Industries, Inc. | PBX |
| Aug 4, 2015 | K143554 | Venus Legacy CX Venus Concept , Ltd. | PBX |
| May 1, 2015 | K150035 | V10 system Viora , Ltd., IL | PBX |
| Jan 15, 2015 | K143040 | Exilis XP BTL Industries, Inc. | PBX |
| Sep 5, 2014 | K133739 | TRUSCULPT Cutera, Inc. | PBX |
| Feb 20, 2014 | K132949 | PELLEFIRM Ellman International, Inc. | PBX |
| Nov 2, 2012 | K122389 | TRUSCULPT Cutera, Inc. | PBX |
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