The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode System With The Morpheus8 (fractora) Applicators.
| Device ID | K192695 |
| 510k Number | K192695 |
| Device Name: | InMode System With The Morpheus8 (Fractora) Applicators |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2019-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290016633624 | K192695 | 000 |
| 07290016633634 | K192695 | 000 |
| 07290016633627 | K192695 | 000 |
| 07290016633672 | K192695 | 000 |
| 07290016633412 | K192695 | 000 |