SILK'N FX

Light Based Over The Counter Wrinkle Reduction

HOME SKINOVATIONS LTD.

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

Pre-market Notification Details

Device IDK110301
510k NumberK110301
Device Name:SILK'N FX
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit,  IL 20692
ContactAmir Waldman Ph. D.
CorrespondentAmir Waldman Ph. D.
HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit,  IL 20692
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-02
Decision Date2011-08-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290106259218 K110301 000
07290015764636 K110301 000
17290015418611 K110301 000
00866057000314 K110301 000

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