Lap.Ox Laparoscopic Tissue Oximeter— 510(k) K250519

Substantially Equivalent

Vioptix, Inc.

FDA 510(k) clearance K250519 for Lap.Ox Laparoscopic Tissue Oximeter, Substantially Equivalent on 2025-06-26. Applicant: Vioptix, Inc..

Clearance details

Applicant: Vioptix, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2025-02-21
Decision date: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.