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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 K180511
Device Name eon
Applicant
Dominion Aesthetic Technologies, Inc.
2431 Aloma Avenue Suite # 225
winter park,  FL  32792
Applicant Contact ahmed mohammed
Correspondent
Dominion Aesthetic Technologies, Inc.
2431 Aloma Avenue Suite # 225
winter park,  FL  32792
Correspondent Contact ahmed mohammed
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/27/2018
Decision Date 06/12/2019
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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