Nutra Face Lift Model PE8050

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

NUTRA LUXE MD, LLC

The following data is part of a premarket notification filed by Nutra Luxe Md, Llc with the FDA for Nutra Face Lift Model Pe8050.

Pre-market Notification Details

Device IDK150826
510k NumberK150826
Device Name:Nutra Face Lift Model PE8050
ClassificationStimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant NUTRA LUXE MD, LLC 6835 INTERNATIONAL CENTER BLVD UNIT 4-5 Fort Myers,  FL  33912
ContactPeter Von Berg
CorrespondentGloria Avendano
NUTRA LUXE MD, LLC 12801 COMMONWEALTH DR. UNITS 2-6 Fort Myers,  FL  33913
Product CodeNFO  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-30
Decision Date2016-02-10
Summary:summary

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