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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 K252753
Device Name Vydence Family of Lasers
Applicant
Vydence Medical Industria E Commercio Ltda
Rua Also Germano Klein, 359 Cep:13.573-470-Caixa Postal 772
Sal Carlos,  BR 13.573.470
Applicant Contact Eduardo Gabriel
Correspondent
Hoy & Associates Regulatory Consulting, LLC
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Connie Hoy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/29/2025
Decision Date 01/24/2026
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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