Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042929028

FEI Number

3042929028

Entity Name

OPXION TECH. INCORPORATION

City/State/Country

Linkou Dist New Taipei, TW

Establishment Address

14F-4, No. 266, Sec. 1,, Wenhua 2nd Rd, Linkou Dist New Taipei 244257, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OPXION Tech. Incorporation (Owner Number: 10094965)

Owner / Operator Contact Address

14F-4, No. 266, Sec. 1,, Wenhua 2nd Rd, Linkou Dist, TW-NWT 244257, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242924

PMA Number

N/A

All Registered Proprietary Names

OPXION Optical Skin Viewer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2026-01-11

Official Correspondent

Bo-Huei Huang

US Agent Details

Claudia Wen Email: usagent.claudiawen@gmail.com Phone: (626) 5890926

Related Public Records

Same Entity

OPXION Tech. Incorporation

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K183320	St. Jude Medical (Now Abbott Medical)	Ilumien Optis, Optis Integrated, Optis Mobile	2019-04-02
K253459	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	2026-04-24
K210458	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	2021-06-08

Similar Registrations

Registration Number	Establishment Name	Location
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3038165043	ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD.	Hangzhou Zhejiang, CN
3042970803	LEADOPTIK INC.	San Jose, CA, US
3012179728	St. Jude Medical	Roseville, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042929028. Last updated year: 2026. Please use registration number 3042929028 when referencing this establishment in official correspondence.