Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016245408

FEI Number

3016245408

Entity Name

M.I.One Co.,Ltd.

City/State/Country

Wonju-si Gangwon, KR

Establishment Address

233, Usan-ro, Wonju-si Gangwon 26335, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

M.I.One Co.,Ltd. (Owner Number: 10062106)

Owner / Operator Contact Address

233, Usan-ro, Wonju-si, KR-42 26335, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Insight-IL Insight-I Insight-I+ CW-2000, LED-Z1000, CCU-2200, CH-2200, CG-2200 IC-3000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2019-12-19
FTT	Camera, Still, Surgical	General, Plastic Surgery	Class 1	878.4160	2019-12-19
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2019-12-19

Official Correspondent

DooHwan Lee

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

M.I.One Co.,Ltd.

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

View Entity Profile →

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3004001706	BR SURGICAL LLC	Jacksonville, FL, US
1820334	Cook Incorporated	Bloomington, IN, US
9681260	Boston Scientific Limited	GALWAY, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016245408. Last updated year: 2026. Please use registration number 3016245408 when referencing this establishment in official correspondence.