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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Disruption Of Adipocyte Cells For Aesthetic Use
510(k) Number K222226
Device Name EON
Applicant
Dominion Aesthetic Technologies, Inc.
2431 Aloma Ave. Suite 300
Winter Park,  FL  32792
Applicant Contact Ahmed Mohammed
Correspondent
Dominion Aesthetic Technologies, Inc.
2431 Aloma Ave. Suite 300
Winter Park,  FL  32792
Correspondent Contact Ahmed Mohammed
Regulation Number878.5400
Classification Product Code
PKT  
Date Received07/25/2022
Decision Date 02/17/2023
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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