# K250519: Lap.Ox™ Laparoscopic Tissue Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Vioptix, Inc.
- Decided: Jun 26, 2025 after 125 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K963903 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233488: Intra.Ox™ 2.0 Handheld Tissue Oximeter, Vioptix, Inc. (2024) Summary page 5.

## Indications for use
The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.

Source page: https://510kreport.com/device/K250519
Methodology: https://510kreport.com/methodology