The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode Rf Multi-system.
| Device ID | K201150 |
| 510k Number | K201150 |
| Device Name: | InMode RF Multi-System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | InMode Ltd. Tabor Building, Shaar Yokneam Yokneam 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 |
| Subsequent Product Code | ISA |
| Subsequent Product Code | NUV |
| Subsequent Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-29 |
| Decision Date | 2020-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633320 | K201150 | 000 |