The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode System With Fractora3d/3d-90 Applicators.
| Device ID | K180189 |
| 510k Number | K180189 |
| Device Name: | InMode System With Fractora3D/3D-90 Applicators |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Inmode MD Ltd. Tabor Building Shaar Yokneam Yoqneam Illt, 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 | 2018-01-23 |
| Decision Date | 2018-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633696 | K180189 | 000 |
| 07290016633719 | K180189 | 000 |