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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K122368
Model 6200416
Device Name WATERLASE IPLUS ALL TISSUE LASER
Original Applicant
BIOLASE TECHNOLOGY, INC.
4 cromwell
irvine,  CA  92618
Original Contact ehab esmail
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/06/2012
Decision Date 05/02/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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