The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silk'n Hst.
| Device ID | K162784 |
| 510k Number | K162784 |
| Device Name: | Silk'n HST |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Home Skinovations Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit, IL 2069200 |
| Contact | Amit Goren |
| Correspondent | Amit Goren A. Stein – Regulatory Affairs Consulting Ltd. 20 Hata’as Str., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2017-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290112450224 | K162784 | 000 |
| 07290015763851 | K162784 | 000 |
| 17290112452013 | K162784 | 000 |
| 17290112451559 | K162784 | 000 |
| 07290019840039 | K162784 | 000 |