MIRADRY SYSTEM

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.

Pre-market Notification Details

Device IDK103014
510k NumberK103014
Device Name:MIRADRY SYSTEM
ClassificationInstrument For Treatment Of Hyperhidrosis
Applicant MIRAMAR LABS, INC. 445 INDIO WAY Sunnyvale,  CA  94085
ContactKathy O'shaughnessy
CorrespondentKathy O'shaughnessy
MIRAMAR LABS, INC. 445 INDIO WAY Sunnyvale,  CA  94085
Product CodeOUB  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-13
Decision Date2011-01-28
Summary:summary

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