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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 K260618
Device Name Ulthera® System
Applicant
Ulthera, Inc.
6501 Six Forks Rd.
Raleigh,  NC  27560
Applicant Contact Scott Jewett
Correspondent
Ulthera, Inc.
6501 Six Forks Rd.
Raleigh,  NC  27560
Correspondent Contact Scott Jewett
Regulation Number878.4590
Classification Product Code
OHV  
Subsequent Product Code
IYO  
Date Received02/25/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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