Data / Medical devices / United States / Sparqtron Corp.
Sparqtron Corp.: FDA-registered device maker in Fremont, CA, United States, 1 510(k) clearance
Sparqtron Corp. is registered with the FDA (registration 3002736133) in Fremont, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002736133
- Address
- 5079 Brandin CT., Fremont, CA, United States, 94538
- Owner or operator
- SPARQTRON CORP. (9065236)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 24, 2014
- Registered through
- 2026
- Brand names listed
- Iridex Cyclo G6 laser system, OCULIGHT TX, Vein-Eye
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vein Location, Liquid Crystal | KZA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 8, 2006 | K062369 | IRIDEX OCULIGHT TX | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
Compare with other makers
Updated November 8, 2006. 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.