The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode System With The Morhpeus8 Applicators.
| Device ID | K200947 |
| 510k Number | K200947 |
| Device Name: | InMode System With The Morhpeus8 Applicators |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-08 |
| Decision Date | 2020-07-02 |