SENSILIGHT/ SENSILIGHT PLUS

Light Based Over-the-counter Hair Removal

EL GLOBAL TRADE LTD.

The following data is part of a premarket notification filed by El Global Trade Ltd. with the FDA for Sensilight/ Sensilight Plus.

Pre-market Notification Details

Device IDK140381
510k NumberK140381
Device Name:SENSILIGHT/ SENSILIGHT PLUS
ClassificationLight Based Over-the-counter Hair Removal
Applicant EL GLOBAL TRADE LTD. TZORAN 4TH ST. Netanya,  IL 42504
ContactShlomit Segman
CorrespondentShlomit Segman
EL GLOBAL TRADE LTD. TZORAN 4TH ST. Netanya,  IL 42504
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-14
Decision Date2014-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060445340029 K140381 000
05060445340005 K140381 000

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