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FDA 510(k) Application Details - K221011
Device Classification Name
More FDA Info for this Device
510(K) Number
K221011
Device Name
AI.ME System
Applicant
Venus Concept USA Inc.
1880 N Commerce Pkwy, Suite 2
Weston, FL 33326 US
Other 510(k) Applications for this Company
Contact
William H McGrail
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QAI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2022
Decision Date
12/20/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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