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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 K153677
Device Name The 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 Received12/21/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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