The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silkn Blue.
| Device ID | K121435 |
| 510k Number | K121435 |
| Device Name: | SILKN BLUE |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit, IL 20692 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2013-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290015418628 | K121435 | 000 |