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FDA 510(k) Applications Submitted by Bioness Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K103343
11/15/2010
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
BIONESS INC.
K200262
02/03/2020
L100 Go System
Bioness Inc.
K190285
02/11/2019
L300 Go System
Bioness Inc.
K191587
06/14/2019
L360 Thigh System
Bioness Inc.
K162407
08/29/2016
L300 Go System
BIONESS INC.
K190047
01/09/2019
StimRouter Neuromodulation System
Bioness Inc.
K200482
02/27/2020
StimRouter Neuromodulation System
Bioness Inc.
K211965
06/24/2021
StimRouter Neuromodulation System
Bioness Inc.
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