Data / Medical devices / United States / Vioptix, Inc.
Vioptix, Inc.: FDA-registered device maker in Newark, CA, United States, 6 510(k) clearances
Vioptix, Inc. is registered with the FDA (registration 3003965364) in Newark, CA, United States. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated June 26, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003965364
- Address
- 39655 Eureka Dr, Newark, CA, United States, 94560
- Owner or operator
- VIOPTIX, INC. (9051676)
- Roles
- Manufacturer
- First device listed
- October 31, 2007
- Registered through
- 2027
- Brand names listed
- Intra.Ox 2 Hand Held Tissue Oximeter, Intra.Ox 2 Handheld Tissue Oximeter, Intra.Ox 2 Tissue Oximeter, Lap.Ox Laparoscopic Tissue Oximeter, ODISsey Tissue Oximeter, T.Ox Tissue Oximeter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | 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 26, 2025 | K250519 | Lap.Ox Laparoscopic Tissue Oximeter | MUD | Substantially Equivalent | ViOptix, Inc. | accessdata.fda.gov |
| February 28, 2024 | K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter | MUD | Substantially Equivalent | Vioptix, Inc. | accessdata.fda.gov |
| May 3, 2022 | K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | MUD | Substantially Equivalent | Vioptix, Inc. | accessdata.fda.gov |
| September 16, 2019 | K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | MUD | Substantially Equivalent | Vioptix, Inc. | accessdata.fda.gov |
| July 1, 2014 | K141234 | ODISSEY TISSUE OXIMETER | MUD | Substantially Equivalent | Vioptix, Inc. | accessdata.fda.gov |
| January 10, 2005 | K042657 | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 | MUD | Substantially Equivalent | Vioptix, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 26, 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.