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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K231952
Device Name MEDILIGHT
Applicant
Medicreations, LLC
6370 Annie Oakley Dr.
Las Vegas,  NV  89120
Applicant Contact Anthony Hardy
Correspondent
Medicreations, LLC
6370 Annie Oakley Dr.
Las Vegas,  NV  89120
Correspondent Contact Anthony Hardy
Regulation Number878.4810
Classification Product Code
ONF  
Date Received06/30/2023
Decision Date 09/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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