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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K252369
Device Name Boston Pico755
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 Cao Hongmei
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/30/2025
Decision Date 01/21/2026
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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