Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013557681

FEI Number

3013557681

Entity Name

STARMED CO.,LTD

City/State/Country

Ilsandong-gu, Goyang-si Gyeonggi, KR

Establishment Address

(Jungsan-dong, Daebang-Triplaon Business, Tower),B-dong, 4F&12F, 158, Haneulmaeul-ro, Ilsandong-gu, Goyang-si Gyeonggi 10355, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STARmed Co.,Ltd (Owner Number: 10054440)

Owner / Operator Contact Address

(Jungsan-dong, Daebang-Triplaon Business, Tower),B-dong, 4F & 12F, 158, Haneulmaeul-ro, Ilsandong-gu, Goyang-si, KR-41 10355, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203795

PMA Number

N/A

All Registered Proprietary Names

VIVA combo RF Generator star RF Electrode VIVA combo RF System ELRA Electrode, 7-4B18S ELRA Electrode, 7-2B11S ELRA Electrode, 7-4B33S ELRA Electrode, 7-4B18L ELRA Electrode, 7-2B22L ELRA Electrode, 7-2B22S ELRA Electrode, 7-2B11L ELRA Electrode, 7-4B33L EUSRA RF Electrode VIVA Pump, VP01 VENISTAR, 7-VENI0070N VVR Generator, VVR10 VENISTAR, 3-VENI0030N VIVA Pump, VP01-1 VENISTAR, 3-VENI003090N VENISTAR, 7-VENI007090N VIVA combo RF System VIVA RF Electrode star RF Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-02-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-03-21
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-10-30
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2018-09-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-09-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-02-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-03-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-05

Official Correspondent

Honggeun Lee

US Agent Details

Ayoung Kim Business: STARmed America Inc. Email: ayoung@starmed-america.com Phone: (323) 6920028

Related Public Records

Same Entity

STARmed Co.,Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0037-05	N/A	2	NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V

Similar Registrations

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3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013557681. Last updated year: 2026. Please use registration number 3013557681 when referencing this establishment in official correspondence.