The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silk'n Flash N Go.
| Device ID | K103184 |
| 510k Number | K103184 |
| Device Name: | SILK'N FLASH N GO |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | HOME SKINOVATIONS LTD. APOLO BUILDING POB 533 Yokneam Illit, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman HOME SKINOVATIONS LTD. APOLO BUILDING POB 533 Yokneam Illit, IL 20692 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-29 |
| Decision Date | 2010-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016627855 | K103184 | 000 |
| 17290015763278 | K103184 | 000 |
| 17290013587869 | K103184 | 000 |
| 27290112450559 | K103184 | 000 |