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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 K180623
Device Name Ulthera System
Applicant
Ulthera, Inc
1840 South Stapley Drive Suite 200
Mesa,  AZ  85204
Applicant Contact Jessica Newhard
Correspondent
Ulthera, Inc
1840 South Stapley Drive Suite 200
Mesa,  AZ  85204
Correspondent Contact Steve Kachelmeyer
Regulation Number878.4590
Classification Product Code
OHV  
Subsequent Product Code
IYO  
Date Received03/09/2018
Decision Date 05/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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