The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode System With Tone Applicator.
| Device ID | K192249 |
| 510k Number | K192249 |
| Device Name: | InMode System With Tone Applicator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | InMode Ltd. Tabor Building, Shaar Yokneam Yokneam Illit, IL 2069200 |
| Contact | Amit Goren |
| Correspondent | Amit Goren A. Stein-Regulatory Affaris Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, IL 2069200 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2019-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633566 | K192249 | 000 |