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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
Device Name WATERLASE IPLUS ALL TISSUE LASER
Applicant
BIOLASE TECHNOLOGY, INC.
4 CROMWELL
IRVINE,  CA  92618
Applicant Contact EHAB ESMAIL
Correspondent
BIOLASE TECHNOLOGY, INC.
4 CROMWELL
IRVINE,  CA  92618
Correspondent Contact EHAB ESMAIL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/06/2012
Decision Date 05/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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