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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser, dental, soft tissue
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Product CodeNVK
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
KAVO
  SUBSTANTIALLY EQUIVALENT 1

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 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Zap Lasers LLC II Jan-21-2010

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