The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode System With Vtone Applicator.
| Device ID | K200293 |
| 510k Number | K200293 |
| Device Name: | InMode System With VTone Applicator |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | InMode Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit, IL 2069200 |
| Contact | Amit Goren |
| Correspondent | Amit Goren A. Stein – Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-05 |
| Decision Date | 2020-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633597 | K200293 | 000 |
| 07290016633610 | K200293 | 000 |