Data / Medical devices / United States / Leadoptik Inc.
Leadoptik Inc.: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Leadoptik Inc. is registered with the FDA (registration 3042970803) in San Jose, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042970803
- Address
- 2380 Qume Dr Ste A, San Jose, CA, United States, 95131
- Owner or operator
- Leadoptik Inc. (10094418)
- Roles
- Manufacturer
- First device listed
- January 7, 2026
- Registered through
- 2026
- Brand names listed
- LIA Console, LIA-1 Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope Accessory | KTI | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| December 19, 2025 | K251730 | LIA Console (542-7) | NQQ | Substantially Equivalent | Leadoptik, Inc. | accessdata.fda.gov |
| December 19, 2025 | K251402 | LIA-1 Catheter (542-1) | KTI | Substantially Equivalent | Leadoptik, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Optical Coherence Tomography (Oct)
- All makers of Bronchoscope Accessory
Updated December 19, 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.