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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K090580
Device Name THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
Applicant
Solta Medical, Inc.
25881 Industrial Blvd.
Haywood,  CA  94043
Applicant Contact HEATHER MACFALLS
Correspondent
Solta Medical, Inc.
25881 Industrial Blvd.
Haywood,  CA  94043
Correspondent Contact HEATHER MACFALLS
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
ISA  
Date Received03/03/2009
Decision Date 06/26/2009
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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