DERMATOLOGIC TREATMENT SYSTEM (DTS) G2

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 Dermatologic Treatment System (dts) G2.

Pre-market Notification Details

Device IDK082819
510k NumberK082819
Device Name:DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
ClassificationSystem, Ablation, Microwave And Accessories
Applicant MIRAMAR LABS, INC. 199 JEFFERSON DR. Menlo Park,  CA  94025
ContactKathy O'shaughnessy
CorrespondentKathy O'shaughnessy
MIRAMAR LABS, INC. 199 JEFFERSON DR. Menlo Park,  CA  94025
Product CodeNEY  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-25
Decision Date2009-03-20
Summary:summary

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