Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014661462

FEI Number

3014661462

Entity Name

OPTOLANE TECHNOLOGIES, INC.

City/State/Country

Yongin-si Gyeonggi, KR

Establishment Address

A-301, 3F, 357, Guseong-ro, Giheung-gu, Yongin-si Gyeonggi 16914, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OPTOLANE Technologies, Inc. (Owner Number: 10080147)

Owner / Operator Contact Address

A-301, 3F, 357, Guseong-ro, Giheung-gu, Yongin-si, KR-41 16914, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LOAA Analyzer LOAA-M System LOAA-M Powerbox System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2021-01-24

Official Correspondent

Doyoung Lee

US Agent Details

April Lee Business: Withus Group Inc Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

OPTOLANE Technologies, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014661462. Last updated year: 2026. Please use registration number 3014661462 when referencing this establishment in official correspondence.