The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Rf System.
| Device ID | K151793 |
| 510k Number | K151793 |
| Device Name: | InMode RF System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | INMODE MD LTD. TABOR BUILDING, SHAAR YOKNEAM Yoqneam Illit, IL 2069200 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein 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 | 2015-07-01 |
| Decision Date | 2016-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633344 | K151793 | 000 |
| 07290016633337 | K151793 | 000 |
| 07290016633016 | K151793 | 000 |
| 17290016633211 | K151793 | 000 |