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FDA 510(k) Applications Submitted by Venus Concept USA Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K142910
10/06/2014
Legacy BX
Venus Concept USA Inc.
K213308
10/04/2021
Venus BlissMAX
Venus Concept USA Inc.
K221011
04/05/2022
AI.ME System
Venus Concept USA Inc.
K220592
03/01/2022
Venus BlissMAX
Venus Concept USA Inc.
K190743
03/22/2019
Venus Bliss
Venus Concept USA Inc.
K200786
03/26/2020
Venus Epileve
Venus Concept USA Inc.
K191065
04/22/2019
Venus VivaTM
Venus Concept USA Inc.
K201164
05/01/2020
Venus Viva MD Device
Venus Concept USA Inc.
K211461
05/11/2021
Family of Venus RF Systems - Venus Freedom
Venus Concept USA Inc.
K191528
06/10/2019
Venus Legacy Pro Device
Venus Concept USA Inc.
K182094
08/03/2018
Family of Venus RF Systems - Heal
Venus Concept USA Inc.
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