The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Plus System.
| Device ID | K153568 |
| 510k Number | K153568 |
| Device Name: | InMode Plus System |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | InMode MD Ltd. Tabor Building, Shaar Yokneam, POB 44 Yoqneam, IL 20692 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. STEIN- REGULATORY AFFAIRS CONSULTING LTD. 20 HATA'AS STR., SUITE 102 Kfar Saba, IL 44425 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633306 | K153568 | 000 |
| 07290016633245 | K153568 | 000 |
| 07290016633535 | K153568 | 000 |