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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K252412
Device Name Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact Derek Greene
Correspondent
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact Derek Greene
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/01/2025
Decision Date 10/31/2025
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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