The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silk'n Infinity.
Device ID | K171433 |
510k Number | K171433 |
Device Name: | Silk'n Infinity |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | Home Skinovations Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit, IL |
Contact | Amit Goren |
Correspondent | Amit Goren A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, IL |
Product Code | OHT |
Subsequent Product Code | NFO |
Subsequent Product Code | ONF |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-15 |
Decision Date | 2017-08-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17290015764756 | K171433 | 000 |
27290019840255 | K171433 | 000 |
27290019840248 | K171433 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SILK'N INFINITY 86910868 5393885 Live/Registered |
Home Skinovations Ltd. 2016-02-17 |