Lap.Ox Laparoscopic Tissue Oximeter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250519 FDA 510(k)
- FDA Product Code
- MUD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lap.Ox Laparoscopic Tissue Oximeter is a device intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy. It is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopic procedures.
The device is supplied as a reusable instrument and is indicated for use in laparoscopic settings. It has received FDA 510(k) clearance under K number K250519 and is classified as a Class II device under regulation number 870.2700 with product code MUD.
Frequently asked questions
What is the Lap.Ox Laparoscopic Tissue Oximeter used for?
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. It is used for monitoring patients during circulatory or perfusion assessment in laparoscopic procedures, providing real-time tissue oxygenation data to support clinical decision-making.
Is the Lap.Ox Laparoscopic Tissue Oximeter reusable or single-use?
The Lap.Ox Laparoscopic Tissue Oximeter is supplied as a reusable instrument, meaning it is designed for multiple uses after proper cleaning and disinfection between procedures. This is explicitly stated in the device description, which confirms its reusable nature for laparoscopic settings.
What regulatory clearance does the Lap.Ox Laparoscopic Tissue Oximeter have?
The Lap.Ox Laparoscopic Tissue Oximeter has received FDA 510(k) clearance under K number K250519, as stated in the device data. It is classified as a Class II device under regulation number 870.2700 with product code MUD, and the clearance type is Traditional.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vioptix, Lap.Ox™ Laparoscopic Tissue Oximeter (K250519) — FDA 510(k) | Innolitics, PDF ViOptix, Inc. -Ng - accessdata.fda.gov, K250519 FDA 510 (k) - Lap.Ox Laparoscopic Tissue Oximeter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250519 | Class II | Active |
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Manufacturer
- Manufacturer
- Vioptix, Inc.
Sources (1)
- FDA 510(k) K250519 24 fields · synced Sep 26, 2026