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JEISYS MEDICAL INC.

Matched from indexed company URL: Jeisys Medical Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30069851633006985163JEISYS MEDICAL INC.1N2026-01-01307, 308, 401, 410, Daeryung Techno Town 8th, 96 Gamasan-ro, Geu Seoul KR 08501
30337156993033715699JEISYS MEDICAL NORTH AMERICA INC1Y2026-01-0170 Blanchard Rd Ste 303 Burlington MA US 01803

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3317611614757848K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)GEX2025-10-03
863741689288780K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)GEX2025-10-03
3317611431202942K250065DENSITY; DENZA; DENSITY NoirGEI2025-07-08
863741683210992K250065DENSITY; DENZA; DENSITY NoirGEI2025-07-08
863741366576259K231287POTENZAGEI2024-11-05
3317611329351106K231216POTENZAGEI2024-12-10
863741943454786K231216POTENZAGEI2024-12-10
863741255885443K230663DensityGEI2023-08-14
3317612055586818K230663DensityGEI2023-08-14
3317611125058235K223685SmoothCool HR SystemGEX2023-01-04
863741368483270K223685SmoothCool HR SystemGEX2023-01-04
863741702477466K213484SmoothCool HR SystemGEX2022-04-20
863741641977893K201685PotenzaGEI2021-01-19
3317611689394100K201685PotenzaGEI2021-01-19
863741843883411K192545PotenzaGEI2020-02-20
863741149697693K183284INTRAcel RF Microneedle SystemGEI2020-01-15
3317611826411274K183284INTRAcel RF Microneedle SystemGEI2020-01-15
3317611285190298K181896LIPOcelOHV2019-10-18
863741378134775K181896LIPOcelOHV2019-10-18
863741009359353K162169EdgeOne CO2 LaserGEX2016-10-27
863741736966020K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemGEI2016-07-21
863741425370092K142833INTRAGenOUH2015-06-04
863741746698566K141861HILTHERA 4.0ILY2015-01-07
863741741062373K122922E-BEAM ND: YAG LASERGEX2013-01-10
3317611850145479K100590EDGE CO2 LASER SYSTEMONG2010-11-10
863741996706039K100590EDGE CO2 LASER SYSTEMONG2010-11-10
863741287479370K100098PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICEGEX2010-08-13
3317611322098152K092326SMOOTHCOOLONF2010-03-05
863741973117832K092326SMOOTHCOOLONF2010-03-05
863741697315030K082911SMOOTHCOOL HR SYSTEMGEX2008-12-19
863741201616096K072833P-NAIN SYSTEMGEX2008-01-24
863741731427254

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI132025-07-08
GEX102025-10-03
OHV22019-10-18
OUH22015-06-04
ONG22010-11-10
ONF22010-03-05
ILY12015-01-07

PMN#

GUDID#

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