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Jeisys Medical North America Inc: FDA-registered device maker in Burlington, MA, United States, 10 510(k) clearances

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

Jeisys Medical North America Inc is registered with the FDA (registration 3033715699) in Burlington, MA, United States. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 3, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3033715699
Address: 70 Blanchard Rd Ste 303, Burlington, MA, United States, 01803
Owner or operator: JEISYS MEDICAL NORTH AMERICA INC (10091463)
Roles: Complaint file establishment
First device listed: February 24, 2025
Registered through: 2026
Brand names listed: DENSITY, DENSITY Noir, DENSITY; DENSITY Noir; DENZA, DENZA, EdgeOne, Intracel Pro, Lipocel, Potenza and more

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment	accessdata.fda.gov
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	OHV	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Complaint file establishment	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Complaint file establishment	accessdata.fda.gov
Skin Resurfacing Rf Applicator	OUH	2	Complaint file establishment	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
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
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
January 19, 2021	K201685	Potenza	GEI	Substantially Equivalent	Jeisys Medical, Inc.	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
November 10, 2010	K100590	EDGE CO2 LASER SYSTEM	ONG	Substantially Equivalent	Jm System Co., Ltd.	accessdata.fda.gov
March 5, 2010	K092326	SMOOTHCOOL	ONF	Substantially Equivalent	Jeisys Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 3, 2025. 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.