The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode Multi-system.
| Device ID | K221571 |
| 510k Number | K221571 |
| Device Name: | InMode Multi-system |
| Classification | Powered Laser Surgical Instrument |
| Applicant | InMode Ltd. Tabor Building, Shaar Yokneam Yokneam Illit, IL 2069200 |
| Contact | Amit Goren |
| Correspondent | Amit Goren A. Stein-Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Sute 21 Kfar Saba, IL 4442518 |
| Product Code | GEX |
| Subsequent Product Code | GEI |
| Subsequent Product Code | ISA |
| Subsequent Product Code | NUV |
| Subsequent Product Code | ONF |
| Subsequent Product Code | PBX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-31 |
| Decision Date | 2022-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290019863236 | K221571 | 000 |
| 07290019863311 | K221571 | 000 |
| 07290016633726 | K221571 | 000 |