Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010952064

FEI Number

3010952064

Entity Name

CHUNGWOO CO., LTD.

City/State/Country

Geumcheon-gu Seoul, KR

Establishment Address

(Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro, Geumcheon-gu Seoul 08591, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CHUNGWOO CO., LTD. (Owner Number: 10087784)

Owner / Operator Contact Address

(Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro, Geumcheon-gu, KR-11 08591, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233120

PMA Number

N/A

All Registered Proprietary Names

Electrode LIFT (Model: 2X80) Neutral Pad (Model: 9541C) Neutral Cable (Model: CWM-910T-H22-1) Hand Piece SMART (Model: HP20-180) Hand Piece LIPO (Model: HP40-300) APOLEX Tite (Model: CWM-910T) Hand Piece Electrode LIPO (Model: AE40-300) Foot Switch (Model: CWM-910T-H21) Electrode LIPO (Model: 4X300) Power cable (Models: SP-30H, IS-14) Electrode SMART (Model: 2X180) Revive (Model: CWM-910T) Retraction (Model: CWM-910T) Hand Piece LIFT (Model: HP20-80) Hand Piece Electrode SMART (Model: AE20-180) Hand Piece Electrode LIFT (Model: AE20-80) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C25, CWM-930S_ELLISYS ST-S25) Foot Switch (Model: CWM-930S-H13) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C49, CWM-930S_ELLISYS ST-S49) Bi-polar Hand piece Cable (Model: CWM-930S-H20) Bi-polar Hand piece (Model: CWM-930S-Y01) Bi-polar Hand piece Suction Filter (Model: CWM-930S-Y02) Neutral Pad (Model: 9571C) ELLISYS SENSE (Model: CWM-930S) FIXER DV9 (Model: CWM-930S) Sterile Micro Needle (Model: CWM-930S_ELLISYS TIP-1) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C14, CWM-930S_ELLISYS ST-S14) Neutral Cable (Model: CWM-930S-H37) Mono-polar Hand piece (Model: CWM-930S-Y03) Sterile Micro Needle ELLISYS ST (Model: CWM-930S_ELLISYS ST-S36) Power Cable (Model: SP-30H, IS-14)

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	2023-04-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-29

Official Correspondent

IL KWON LEE

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

CHUNGWOO 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

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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 3010952064. Last updated year: 2026. Please use registration number 3010952064 when referencing this establishment in official correspondence.