NuBrilliance Light Pain Therapy

Lamp, Infrared, Therapeutic Heating

WELLQUEST INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Wellquest International, Inc. with the FDA for Nubrilliance Light Pain Therapy.

Pre-market Notification Details

Device IDK150554
510k NumberK150554
Device Name:NuBrilliance Light Pain Therapy
ClassificationLamp, Infrared, Therapeutic Heating
Applicant WELLQUEST INTERNATIONAL, INC. 230 FIFTH AVE SUITE 800 New York,  NY  10001
ContactYveth Kan
CorrespondentCarrie Hetrick
EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE SUITE 1400 Austin,  TX  78701
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-04
Decision Date2015-10-06
Summary:summary

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