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FDA 510(k) Applications Submitted by JEISYS MEDICAL, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K201685
06/22/2020
Potenza
Jeisys Medical, Inc.
K153727
12/28/2015
INTRAcel Premium Fractional RF Micro Needle (FRM) System
JEISYS MEDICAL, INC.
K092326
08/04/2009
SMOOTHCOOL
JEISYS MEDICAL, INC.
K082911
09/30/2008
SMOOTHCOOL HR SYSTEM
JEISYS MEDICAL, INC.
K072833
10/03/2007
P-NAIN SYSTEM
JEISYS MEDICAL, INC.
K142833
09/30/2014
INTRAGen
JEISYS MEDICAL, INC.
K141861
07/10/2014
HILTHERA 4.0
JEISYS MEDICAL, INC.
K181896
07/16/2018
LIPOcel
Jeisys Medical, Inc.
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