The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Evolve System With The T3 Applicator.
| Device ID | K210877 |
| 510k Number | K210877 |
| Device Name: | Evolve System With The T3 Applicator |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | InMode Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit, IL 2069200 |
| Contact | Amit Goren |
| Correspondent | Amit Goren A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Suite 21 Kfar Saba, IL 4442518 |
| Product Code | PBX |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-24 |
| Decision Date | 2021-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633498 | K210877 | 000 |