The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Emface Device.
| Device ID | K191855 |
| 510k Number | K191855 |
| Device Name: | EmFace Device |
| 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 | 2019-07-10 |
| Decision Date | 2019-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633504 | K191855 | 000 |
| 17290016633549 | K191855 | 000 |
| 07290016633559 | K191855 | 000 |
| 07290016633542 | K191855 | 000 |