RejuvatoneMD

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

TROPHY SKIN, INC.

The following data is part of a premarket notification filed by Trophy Skin, Inc. with the FDA for Rejuvatonemd.

Pre-market Notification Details

Device IDK152199
510k NumberK152199
Device Name:RejuvatoneMD
ClassificationStimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant TROPHY SKIN, INC. 4372 KENMARE TRAIL Frisco,  TX  75034
ContactImran Karim
CorrespondentSue Anthoney-dewet
AEGIS REGULATORY, INC. 2424 DEMPSTER DRIVE Coralville,  IA  52241
Product CodeNFO  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-06
Decision Date2016-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851561006105 K152199 000

Trademark Results [RejuvatoneMD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REJUVATONEMD
REJUVATONEMD
86096250 5418457 Live/Registered
Trophy Skin, Inc.
2013-10-20

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