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FDA 510(k) Application Details - K211461
Device Classification Name
More FDA Info for this Device
510(K) Number
K211461
Device Name
Family of Venus RF Systems - Venus Freedom
Applicant
Venus Concept USA Inc.
1880 N Commerce Pkwy, Suite 2
Weston, FL 33326 US
Other 510(k) Applications for this Company
Contact
Yoni Iger
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2021
Decision Date
10/14/2021
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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