FDA.reportPublic FDA data

JEISYS MEDICAL NORTH AMERICA INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
3317611431202942K250065DENSITY; DENZA; DENSITY NoirGEI2025-07-08
3317611329351106K231216POTENZAGEI2024-12-10
3317612055586818K230663DensityGEI2023-08-14
3317611125058235K223685SmoothCool HR SystemGEX2023-01-04
3317611689394100K201685PotenzaGEI2021-01-19
3317611826411274K183284INTRAcel RF Microneedle SystemGEI2020-01-15
3317611285190298K181896LIPOcelOHV2019-10-18
3317611850145479K100590EDGE CO2 LASER SYSTEMONG2010-11-10
3317611322098152K092326SMOOTHCOOLONF2010-03-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI52025-07-08
GEX22025-10-03
OHV12019-10-18
ONG12010-11-10
ONF12010-03-05