The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Wmbody Device.
| Device ID | K131362 |
| 510k Number | K131362 |
| Device Name: | INMODE WMBODY DEVICE |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | INMODE MD LTD. 20 HATA'AS STR., SUITE 102 Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein INMODE MD LTD. 20 HATA'AS STR., SUITE 102 Kfar Saba, IL 44425 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633085 | K131362 | 000 |