Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019565615

FEI Number

3019565615

Entity Name

HEALUX CO.,LTD

City/State/Country

Geumcheon-gu, Seoul, KR

Establishment Address

A509, Dusan-ro 70,, Geumcheon-gu, Seoul 08584, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Healux Co.,Ltd (Owner Number: 10081940)

Owner / Operator Contact Address

A509, Dusan-ro 70,, Geumcheon-gu,, KR-11 08584, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HealFusion Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2024-01-29

Official Correspondent

Do Yeun Kim

US Agent Details

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

Related Public Records

Same Entity

Healux Co.,Ltd

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

View Entity Profile →

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3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019565615. Last updated year: 2026. Please use registration number 3019565615 when referencing this establishment in official correspondence.