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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 K253765
Device Name VANISH PRO
Applicant
Ddc Technologies, Inc.
311 Woods Ave.
Oceanside,  NY  11572
Applicant Contact Joseph Buscarello
Correspondent
Ddc Technologies, Inc.
311 Woods Ave.
Oceanside,  NY  11572
Correspondent Contact Joseph Buscarello
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/25/2025
Decision Date 04/22/2026
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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