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510(k) K082819

DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 by Miramar Labs, Inc. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2009
Date Received
September 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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  • K103014 — MIRADRY SYSTEM (January 28, 2011)

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