The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Sr Ipl Device.
| Device ID | K123860 |
| 510k Number | K123860 |
| Device Name: | INMODE SR IPL DEVICE |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| 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 | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-14 |
| Decision Date | 2013-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633115 | K123860 | 000 |
| 07290016633108 | K123860 | 000 |