EpilME

Powered Laser Surgical Instrument

Neauvia North America

The following data is part of a premarket notification filed by Neauvia North America with the FDA for Epilme.

Pre-market Notification Details

Device IDK213261
510k NumberK213261
Device Name:EpilME
ClassificationPowered Laser Surgical Instrument
Applicant Neauvia North America 8480 Honeycutt Road Raleigh,  NC  27615
ContactJoy Willard
CorrespondentJoy Willard
Neauvia North America 8480 Honeycutt Road Raleigh,  NC  27615
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-06-02

Trademark Results [EpilME]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPILME
EPILME
97305342 not registered Live/Pending
Neauvia North America, Inc.
2022-03-10

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