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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K221011
Device Name AI.ME System
Applicant
Venus Concept USA, Inc.
1880 N Commerce Pkwy.,
Suite 2
Weston,  FL  33326
Applicant Contact William H McGrail
Correspondent
Venus Concept USA, Inc.
1880 N Commerce Pkwy.,
Suite 2
Weston,  FL  33326
Correspondent Contact William H McGrail
Regulation Number878.4430
Classification Product Code
QAI  
Date Received04/05/2022
Decision Date 12/20/2022
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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