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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 K122528
Model 8850-0001
Device Name ULTHERA SYSTEM
Applicant
ULTHERA, INC.
1840 s stapley dr suite 200
mesa,  AZ  85204
Contact suzon lommel
Regulation Number878.4590
Classification Product Code
OHV  
Date Received08/20/2012
Decision Date 08/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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