The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Plus System.
| Device ID | K172302 |
| 510k Number | K172302 |
| Device Name: | InMode PLUS System |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | InMode MD 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 | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-31 |
| Decision Date | 2017-12-08 |
| Summary: | summary |