MiraDry System MD4000

Instrument For Treatment Of Hyperhidrosis

MIRAMAR LABS, INC.

The following data is part of a premarket notification filed by Miramar Labs, Inc. with the FDA for Miradry System Md4000.

Pre-market Notification Details

Device IDK150419
510k NumberK150419
Device Name:MiraDry System MD4000
ClassificationInstrument For Treatment Of Hyperhidrosis
Applicant MIRAMAR LABS, INC. 2790 WALSH AVENUE Santa Clara,  CA  95051
ContactKathy O'shaughnessy
CorrespondentKathy O'shaughnessy
MIRAMAR LABS, INC. 2790 WALSH AVENUE Santa Clara,  CA  95051
Product CodeOUB  
Subsequent Product CodeMWY
Subsequent Product CodeNEY
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-18
Decision Date2015-06-19
Summary:summary

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