Data / Medical devices / South Korea / Starmed Co.,ltd

Starmed Co.,ltd: FDA-registered device maker in Ilsandong-gu, Goyang-si Gyeonggi, South Korea, 11 510(k) clearances

Name: Starmed Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Starmed Co.,ltd is registered with the FDA (registration 3013557681) in Ilsandong-gu, Goyang-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 26, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3013557681
Address: (Jungsan-dong, Daebang-Triplaon Business Tower),B-dong, 4F&12F, 158, Haneulmaeul-ro, Ilsandong-gu, Goyang-si Gyeonggi, South Korea, 10355
Owner or operator: STARmed Co.,Ltd (10054440)
Roles: Manufacturer
First device listed: March 21, 2017
Registered through: 2027
Brand names listed: ELRA Electrode, 7-2B11L, ELRA Electrode, 7-2B11S, ELRA Electrode, 7-2B22L, ELRA Electrode, 7-2B22S, ELRA Electrode, 7-4B18L, ELRA Electrode, 7-4B18S, ELRA Electrode, 7-4B33L, ELRA Electrode, 7-4B33S and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Electrosurgical	JOS	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	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
May 26, 2026	K252833	VIVA combo RF System	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
November 17, 2025	K251566	TS-RF Generator (STS10)	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
January 30, 2024	K234140	VIVA combo RF System (VIVA combo RF System)	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
October 25, 2023	K233113	ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)	KNS	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
October 25, 2023	K222997	VVR Generator system	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
April 1, 2021	K203795	Star RF Electrode, VIVA RF Electrode	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
April 11, 2019	K181758	ELRA Electrode	KNS	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
January 17, 2019	K183538	VIVA combo RF System	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
September 4, 2018	K181249	EUSRA RF Electrode	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
March 14, 2018	K172012	star RF Electrode, VIVA RF Electrode	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov
March 8, 2017	K163450	VIVA combo RF System	GEI	Substantially Equivalent	Starmed Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 26, 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.