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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 K190007
Device Name Vydence Laser Family
Applicant
Vydence Medical Industria E Comercio Ltda
Rua Aldo Germano Klein, 359
Cep: 13.573-470 - Caixa Postal 772
Ceat - Sao Carlos,  BR 13.573-470
Applicant Contact Kathy Maynor
Correspondent
Vydence Medical
26 Rebecca Ct.
Homosassa,  FL  34446
Correspondent Contact Kathy Maynor
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONF   PDZ  
Date Received01/02/2019
Decision Date 03/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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