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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 K242534
Device Name HandPICO Fractional Laser Handpiece Tip
Applicant
Vydence Medical
Rua Aldo Germano Klein, 359. Ceat
Sao Carlos,  BR 13573-470
Applicant Contact Antonio Olivatto
Correspondent
Vydence Medical
Rua Aldo Germano Klein, 359. Ceat
Sao Carlos,  BR 13573-470
Correspondent Contact Antonio Olivatto
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/26/2024
Decision Date 12/20/2024
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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