MiraDry System

System, Ablation, Microwave And Accessories

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 IDK160141
510k NumberK160141
Device Name:MiraDry System
ClassificationSystem, Ablation, Microwave And Accessories
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 CodeNEY  
Subsequent Product CodeMWY
Subsequent Product CodeOUB
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-21
Decision Date2016-10-31
Summary:summary

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