Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007047889

FEI Number

3007047889

Entity Name

BOMTECH ELECTRONICS CO., LTD.

City/State/Country

Seoul, KR

Establishment Address

322, Gonghang-daero,, Gangseo-gu,, Seoul 07646, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bomtech Electronics Co., Ltd. (Owner Number: 10038846)

Owner / Operator Contact Address

322, Gonghang-daero, Gangseo-gu, Seoul, KR-11 06670, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243097

PMA Number

N/A

All Registered Proprietary Names

JUVPEN MD E-PEN RM STAR EX with RMS Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2025-04-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-03-16

Official Correspondent

Colleen Hong

US Agent Details

Sing-Hong Yeung Business: Bellaire Industry Email: sales@bellaireindustry.com Phone: (631) 9242751

Related Public Records

Same Entity

Bomtech Electronics 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

Registration Number	Establishment Name	Location
3010126182	WOORHI MECHATRONICS	Gunpo-si Gyeonggi, KR
1000561585	DERMALOGICA, LLC	Carson, CA, US
3020704367	CYTRELLIS BIOSYSTEMS, INC.	Woburn, MA, US
3006033709	REFINE USA, LLC	Jacksonville Beach, FL, US
3007544634	Paragon Medical - Mansfield, Bridgemedica	Mansfield, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007047889. Last updated year: 2026. Please use registration number 3007047889 when referencing this establishment in official correspondence.