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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument for treatment of hyperhidrosis
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Soft-tissue coagulation
Product CodeOUB
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
Miramar Labs, Inc.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 90
Use of Device Issue 1
No Information 1
Total Device Problems 92

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Miramar Labs, Inc. II Nov-06-2015
2 Miramar Labs, Inc. II Jun-17-2011

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