Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010164891

FEI Number

3010164891

Entity Name

AGNES MEDICAL CO.,LTD

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

#401-402, 24 Dunchon-daero, 388beon-gil,Jungwon-gu,, Seongnam-si Gyeonggi 13403, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AGNES MEDICAL CO., LTD. (Owner Number: 10049778)

Owner / Operator Contact Address

5F Coco-Plaza B/D 20,, Seohyeon-Ro 210 beon-gil, Bundang-Gu, Seongnam, KR-41 13591, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AGNES-S AGNES AGNES PlazMagik AGNES Ultra AG-CN18G, AG-CN19G, AG-CN20G, AG-CN21G, AG-CN-23G Single Use RF electrode (Needle Type) / GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A AG-CN-23G AG-CN20G AG-CN19G AG-CN18G AG-CN21G

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	2020-12-01
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2020-12-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-07-27
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2022-07-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-03-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-29
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2023-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-08-12
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2023-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

AGNES MEDICAL 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

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 3010164891. Last updated year: 2026. Please use registration number 3010164891 when referencing this establishment in official correspondence.