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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
510(k) Number K134032
Device Name ULTHERA SYSTEM
Applicant
ULTHERA, INC.
2150 S. Country Club Drive
Suite 21
Mesa,  AZ  85210
Applicant Contact ASHLEY FICKETT
Correspondent
ULTHERA, INC.
2150 S. Country Club Drive
Suite 21
Mesa,  AZ  85210
Correspondent Contact ASHLEY FICKETT
Regulation Number878.4590
Classification Product Code
OHV  
Subsequent Product Code
IYO  
Date Received12/31/2013
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01713686
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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