Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014980461

FEI Number

3014980461

Entity Name

HIRONIC CO., LTD.

City/State/Country

Yongin-Si Gyeonggi, KR

Establishment Address

19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-Si Gyeonggi 16827, 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

K233123

PMA Number

N/A

All Registered Proprietary Names

RF Micro Needle Tip (Model: RMT-N25) RM Handpiece PS Tip PS Handpiece RF Micro Needle Tip (Model: RMT-I25) NEW DOUBLO 2 RF Micro Needle Tip (Model: RMT-N49) RM(B) Handpiece RF Micro Needle Tip (Model: RMT-I49) SYNERJET PRO, InPhiuse, WOWJET (Model Name: SP-1002) SILKRO PICOHI Plasonic 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)

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	2025-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-08-21
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	2024-07-29

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
3033524168	Hironic Co., Ltd.	Cheongju-si Chungbuk, 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
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014980461. Last updated year: 2026. Please use registration number 3014980461 when referencing this establishment in official correspondence.