Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019810045

FEI Number

3019810045

Entity Name

Oculight Co.,Ltd.

City/State/Country

Seongnam, KR

Establishment Address

46 Dallaenae-Ro, Sujeong District, Seongnam 13449, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Oculight Co. Ltd. (Owner Number: 10082160)

Owner / Operator Contact Address

46, Dallaenae-ro, Sujeong-gu, Seongnam-si, KR-41 13449, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iChopper iVision

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2024-01-27
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2021-06-21

Official Correspondent

DongHeun Nam

US Agent Details

Ikro Park Business: BIO PROTECH USA INC. Email: Edward22@medimaxtech.com Phone: (909) 4641464

Related Public Records

Same Entity

Oculight Co. Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0307-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019810045. Last updated year: 2026. Please use registration number 3019810045 when referencing this establishment in official correspondence.