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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 K063808
Device Name FRAXEL IV SR LASER SYSTEM
Applicant
Reliant Technologies, Inc.
464 Ellis St.
Mountain View,  CA  94043
Applicant Contact HEATHER TANNER MACFALLS
Correspondent
Reliant Technologies, Inc.
464 Ellis St.
Mountain View,  CA  94043
Correspondent Contact HEATHER TANNER MACFALLS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/22/2006
Decision Date 04/27/2007
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
Predetermined Change
Control Plan Authorized		 No
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