The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Diolaze System.
| Device ID | K180719 |
| 510k Number | K180719 |
| Device Name: | InMode Diolaze System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | InMode MD Ltd. Tabor Building, Shaar Yokneam Yokneam, IL 20692 |
| Contact | Amit Goren |
| Correspondent | Amit Goren A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, IL 44425 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633382 | K180719 | 000 |