The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silk'n Model H5003 Device.
| Device ID | K180279 |
| 510k Number | K180279 |
| Device Name: | Silk'n MODEL H5003 Device |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| 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 | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-31 |
| Decision Date | 2018-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290016633645 | K180279 | 000 |