Data / Medical devices / Taiwan / Opxion Tech. Incorporation
Opxion Tech. Incorporation: FDA-registered device maker in Linkou Dist New Taipei, Taiwan, 1 510(k) clearance
Opxion Tech. Incorporation is registered with the FDA (registration 3042929028) in Linkou Dist New Taipei, Taiwan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042929028
- Address
- 14F-4, No. 266, Sec. 1, Wenhua 2nd Rd, Linkou Dist New Taipei, Taiwan, 244257
- Owner or operator
- OPXION Tech. Incorporation (10094965)
- Roles
- Manufacturer
- First device listed
- January 11, 2026
- Registered through
- 2026
- Brand names listed
- OPXION Optical Skin Viewer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2025 | K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | NQQ | Substantially Equivalent | Opxion Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.