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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 K170758
Device Name Thermage FLX System and Accessories
Applicant
Solta Medical
11720 N. Creek Pkwy. N.
Suite 100
Bothell,  WA  98011
Applicant Contact Melissa Thomas
Correspondent
Melissa Thomas
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact Melissa Thomas
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
ISA  
Date Received03/13/2017
Decision Date 09/22/2017
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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