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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K241832
Device Name Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
Applicant
Boston Aesthetics, Inc.
1521 Concord Pike
Suite 201
Wilmington,  DE  19803
Applicant Contact Hongmei Cao
Correspondent
Boston Aesthetics, Inc.
1521 Concord Pike
Suite 201
Wilmington,  DE  19803
Correspondent Contact Hongmei Cao
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
PBX  
Date Received06/25/2024
Decision Date 02/13/2025
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
Predetermined Change
Control Plan Authorized		 No
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