The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silk'n Fx.
| Device ID | K110301 |
| 510k Number | K110301 |
| Device Name: | SILK'N FX |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit, IL 20692 |
| Contact | Amir Waldman Ph. D. |
| Correspondent | Amir Waldman Ph. D. HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit, IL 20692 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-02 |
| Decision Date | 2011-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290106259218 | K110301 | 000 |
| 07290015764636 | K110301 | 000 |
| 17290015418611 | K110301 | 000 |
| 00866057000314 | K110301 | 000 |