Silk'n Infinity

Light Based Over-the-counter Hair Removal

Home Skinovations Ltd.

The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Silk'n Infinity.

Pre-market Notification Details

Device IDK171433
510k NumberK171433
Device Name:Silk'n Infinity
ClassificationLight Based Over-the-counter Hair Removal
Applicant Home Skinovations Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit,  IL
ContactAmit Goren
CorrespondentAmit Goren
A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba,  IL
Product CodeOHT  
Subsequent Product CodeNFO
Subsequent Product CodeONF
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-15
Decision Date2017-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290015764756 K171433 000
27290019840255 K171433 000
27290019840248 K171433 000

Trademark Results [Silk'n Infinity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILK'N INFINITY
SILK'N INFINITY
86910868 5393885 Live/Registered
Home Skinovations Ltd.
2016-02-17

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