Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021007058

FEI Number

3021007058

Entity Name

KUSNOW

City/State/Country

Yongin Gyeonggi, KR

Establishment Address

184 Jungbu-daero, Giheung-gu, A-1301-2, Yongin Gyeonggi 17095, KR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ChoiceTech Korea (Owner Number: 10083248)

Owner / Operator Contact Address

184 Jungbu-daero, Giheung-gu, A-1301-2, Yongin, KR-41 17095, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BiLumix BiLumix BiLumix Gen 3 Gen 2S Gen 3S Gen 2 BiLumix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOH	Spectacle, Operating (Loupe), Ophthalmic	Ophthalmic	Class 1	886.4770	2021-11-11
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2021-11-11
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2021-11-04
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2021-11-11

Official Correspondent

Wonsuk Choi

US Agent Details

Moonki Jung Business: 3DDEX, LLC Email: ryanj@bilumix.com Phone: (267) 4718605

Related Public Records

Same Entity

ChoiceTech Korea

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 3021007058. Last updated year: 2026. Please use registration number 3021007058 when referencing this establishment in official correspondence.