The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Hair Removal (hr) Device.
| Device ID | K123682 |
| 510k Number | K123682 |
| Device Name: | INMODE HAIR REMOVAL (HR) DEVICE |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-30 |
| Decision Date | 2013-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633375 | K123682 | 000 |
| 07290016633252 | K123682 | 000 |
| 07290016633139 | K123682 | 000 |