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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 K150505
Device Name Cellfina System
Applicant
ULTHERA, INC.
1840 S Stapley Dr Suite 200
Mesa,  AZ  85204
Applicant Contact Suzon Lommel
Correspondent
ULTHERA, INC.
1840 S Stapley Dr Suite 200
Mesa,  AZ  85204
Correspondent Contact Suzon Lommel
Regulation Number878.4790
Classification Product Code
OUP  
Date Received02/25/2015
Decision Date 07/29/2015
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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