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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 K173759
Device Name Thermage CPT System and Accessories
Applicant
Solta Medical
11720 N. Creek Pkway N.
Suite 100
Bothell,  WA  98011
Applicant Contact Ken Nehmer
Correspondent
Solta Medical
351 Buena Vista Ave. E.
Unit 501e
San Francisco,  CA  94117
Correspondent Contact Ken Nehmer
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
ISA  
Date Received12/11/2017
Decision Date 01/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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