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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 K050841
Device Name FRAXEL SR LASER SYSTEM
Applicant
Reliant Technologies, Inc.
260 Sheridan Ave.
Suite 300
Palo Alto,  CA  94306
Applicant Contact HEATHER TANNER
Correspondent
Reliant Technologies, Inc.
260 Sheridan Ave.
Suite 300
Palo Alto,  CA  94306
Correspondent Contact HEATHER TANNER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/01/2005
Decision Date 07/05/2005
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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