Data / Medical devices / South Korea / Jeisys Medical Inc.

Jeisys Medical Inc.: FDA-registered device maker in Seoul, South Korea, 22 510(k) clearances

Name: Jeisys Medical Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jeisys Medical Inc. is registered with the FDA (registration 3006985163) in Seoul, South Korea. It lists 8 device types. The FDA files 22 510(k) clearances under its listings, the newest dated September 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006985163
Address: 307, 308, 401, 410, Daeryung Techno Town 8th, 96 Gamasan-ro, Geumcheon-gu, Seoul, South Korea, 08501
Owner or operator: Jeisys Medical Inc. (10025329)
Roles: Manufacturer
First device listed: April 5, 2008
Registered through: 2026
Brand names listed: 800, 700, 640, 590, 560, 545(V), 530, 530(D), 530(s), 500(s), 420(s), D'Liv, DENSITY, DENSITY Noir, DENSITY, DENSITY Noir, DENZA, DENZA, Edge, Edge ONE and more

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	OHV	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Manufacturer	accessdata.fda.gov
Skin Resurfacing Rf Applicator	OUH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2026	K254185	Potenza Prime	GEI	Substantially Equivalent	Jeisys Medical Incorporated	accessdata.fda.gov
October 3, 2025	K251464	TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)	GEX	Substantially Equivalent	Jeisys Medical Incorporated	accessdata.fda.gov
July 8, 2025	K250065	DENSITY; DENZA; DENSITY Noir	GEI	Substantially Equivalent	Jeisys Medical Incorporated	accessdata.fda.gov
December 10, 2024	K231216	POTENZA	GEI	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
November 5, 2024	K231287	POTENZA	GEI	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
August 14, 2023	K230663	Density	GEI	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
January 4, 2023	K223685	SmoothCool HR System	GEX	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
April 20, 2022	K213484	SmoothCool HR System	GEX	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
January 19, 2021	K201685	Potenza	GEI	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
February 20, 2020	K192545	Potenza	GEI	Substantially Equivalent	Jeisys Medical Incorporated	accessdata.fda.gov
January 15, 2020	K183284	INTRAcel RF Microneedle System	GEI	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
October 18, 2019	K181896	LIPOcel	OHV	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
October 27, 2016	K162169	EdgeOne CO2 Laser	GEX	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
July 21, 2016	K153727	INTRAcel Premium Fractional RF Micro Needle (FRM) System	GEI	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
June 4, 2015	K142833	INTRAGen	OUH	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
January 7, 2015	K141861	HILTHERA 4.0	ILY	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
January 10, 2013	K122922	E-BEAM ND: YAG LASER	GEX	Substantially Equivalent	Eclipse Aesthetics, LLC	accessdata.fda.gov
November 10, 2010	K100590	EDGE CO2 LASER SYSTEM	ONG	Substantially Equivalent	Jm System Co., Ltd.	accessdata.fda.gov
August 13, 2010	K100098	PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE	GEX	Substantially Equivalent	Jm System Co., Ltd.	accessdata.fda.gov
March 5, 2010	K092326	SMOOTHCOOL	ONF	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
December 19, 2008	K082911	SMOOTHCOOL HR SYSTEM	GEX	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov
January 24, 2008	K072833	P-NAIN SYSTEM	GEX	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.