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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 K253245
Device Name Boston 2910 (Boston 2910)
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 Number878.4810
Classification Product Code
GEX  
Date Received09/29/2025
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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