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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 K121700
Device Name ULTHERA SYSTEM
Original Applicant
ULTHERA, INC.
1840 s stapley dr suite 200
mesa,  AZ  85204
Original Contact suzon lommel
Regulation Number878.4590
Classification Product Code
OHV  
Date Received06/07/2012
Decision Date 10/02/2012
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
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