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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered surgical instrument for improvement in the appearance of cellulite
510(k) Number K192185
Device Name The Cellfina System
Applicant
Ulthera, Inc
1840 S. Stapley Dr. Suite 200
mesa,  AZ  85204
Applicant Contact lisa pray
Correspondent
Ulthera, Inc
1840 S. Stapley Dr. Suite 200
mesa,  AZ  85204
Correspondent Contact lisa pray
Regulation Number878.4790
Classification Product Code
OUP  
Date Received08/12/2019
Decision Date 10/09/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Clinical Trials NCT01671839
Reviewed by Third Party No
Combination Product No
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