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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K083595
Device Name EZLASE
Applicant
Biolase Technology, Inc.
4 Cromwell
Irvine,  CA  92618
Applicant Contact IOANA RIZOUI
Correspondent
Biolase Technology, Inc.
4 Cromwell
Irvine,  CA  92618
Correspondent Contact IOANA RIZOUI
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/05/2008
Decision Date 04/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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