Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033524168

FEI Number

3033524168

Entity Name

Hironic Co., Ltd.

City/State/Country

Cheongju-si Chungbuk, KR

Establishment Address

190, Osongsaengmyeong 10-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk 28164, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hironic Co., Ltd. (Owner Number: 10058937)

Owner / Operator Contact Address

19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-si, KR-41 16827, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210084

PMA Number

N/A

All Registered Proprietary Names

RC Handpiece GP Cable RN Handpiece A-FIT RF Needle Tip (Model: A-FIT RN 1.8) A-FIT RF Needle Tip (Model: A-FIT RN 1.5) SILKRO PS Handpiece RF Venus Stick RF Micro Needle Tip (Model: RMT-I25) RV Handpiece Ground Pad A-FIT RF Needle Tip (Model: A-FIT RN 1.2) RF Micro Needle Tip (Model: RMT-I49) RF Micro Needle Tip (Model: RMT-N25) PS Tip RM Handpiece RF Micro Needle Tip (Model: RMT-N49) Plasonic SILKRO

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	2024-07-29
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2024-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-24

Official Correspondent

Jinu Lee

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

Hironic Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014980461	HIRONIC CO., LTD.	Yongin-Si Gyeonggi, KR

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

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
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 3033524168. Last updated year: 2026. Please use registration number 3033524168 when referencing this establishment in official correspondence.