NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE

Light Based Over-the-counter Hair Removal

WELLQUEST INTL., INC.

The following data is part of a premarket notification filed by Wellquest Intl., Inc. with the FDA for Nubrilliance Pulsed Light Hair Removal Device.

Pre-market Notification Details

Device IDK132518
510k NumberK132518
Device Name:NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
ClassificationLight Based Over-the-counter Hair Removal
Applicant WELLQUEST INTL., INC. 816 CONGRESS AVE, STE 1400 Austin,  TX  78701
ContactRobert Seiple, Rac
CorrespondentRobert Seiple, Rac
WELLQUEST INTL., INC. 816 CONGRESS AVE, STE 1400 Austin,  TX  78701
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-12
Decision Date2014-08-17
Summary:summary

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