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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 K231948
Device Name MEDIYAG
Applicant
Medicreations, LLC
6370 Annie Oakley Drv
Las Vegas,  NV  89120
Applicant Contact Anthony Hardy
Correspondent
Medicreations, LLC
6370 Annie Oakley Drv
Las Vegas,  NV  89120
Correspondent Contact Anthony Hardy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/30/2023
Decision Date 10/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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