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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 With Microbeam\Fractional Output
510(k) Number K101490
Device Name FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
Applicant
Thermage, Inc.
25881 Industrial Blvd.
Hayward,  CA  94545
Applicant Contact KRISS FOSS
Correspondent
Thermage, Inc.
25881 Industrial Blvd.
Hayward,  CA  94545
Correspondent Contact KRISS FOSS
Regulation Number878.4810
Classification Product Code
ONG  
Date Received06/01/2010
Decision Date 09/08/2010
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
Recalls CDRH Recalls
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