The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silk'n.
| Device ID | K072906 |
| 510k Number | K072906 |
| Device Name: | SILK'N |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOME SKINOVATIONS LTD. 4 HACHAROSHET ST. POB 7028 Kfar Saba, IL 44640 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman HOME SKINOVATIONS LTD. 4 HACHAROSHET ST. POB 7028 Kfar Saba, IL 44640 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-11 |
| Decision Date | 2008-01-23 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SILK'N 87274308 not registered Live/Pending |
Home Skinovations Ltd. 2016-12-20 |
![]() SILK'N 77771209 3912775 Live/Registered |
Home Skinovations Ltd. 2009-06-30 |
![]() SILK'N 77234462 3613149 Live/Registered |
Home Skinovations Ltd. 2007-07-20 |