The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Diolaze Device.
| Device ID | K142952 |
| 510k Number | K142952 |
| Device Name: | InMode Diolaze Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INMODE MD LTD. TABOR BUILDING, SHAAR YOKNEAM Yokneam Illit, IL 2069200 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-10 |
| Decision Date | 2015-01-13 |
| Summary: | summary |